Other products from "FORESIGHT IMAGING, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00850951007609 TIMS 2000 FEES-L 42M 061000-FEES-L TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities. LLZ System, Image Processing, Radiological 2 TIMS System
2 00850951007593 TIMS 500 S 42M 061000-500 TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functi TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
3 00850951007586 TIMS 2000 SP 42M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
4 00850951007579 TIMS 2000 FEES 42M 061000-FEES TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Fu TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities. LLZ System, Image Processing, Radiological 2 TIMS System
5 00850951007562 TIMS 2000 EN 42M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
6 00850951007555 TIMS 500 S 42N 061000-500 TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functi TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
7 00850951007548 TIMS 2000 FEES-L 42N 061000-FEES-L TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities. LLZ System, Image Processing, Radiological 2 TIMS System
8 00850951007531 TIMS 2000 SP 42N 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
9 00850951007524 TIMS 2000 EN 42N 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
10 00850951007517 TIMS 2000 FEES-L 41M 061000-FEES-L TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities. LLZ System, Image Processing, Radiological 2 TIMS System
11 00850951007500 TIMS 2000 FEES 42N 061000-FEES TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Fu TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities. LLZ System, Image Processing, Radiological 2 TIMS System
12 00850951007494 TIMS 500 S 41M 061000-500 TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functi TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
13 00850951007487 TIMS 500 41M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
14 00850951007470 TIMS 2000 EN 41M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
15 00850951007463 TIMS 2000 SP 41M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
16 00850951007456 TIMS 2000 EN 40M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
17 00850951007449 TIMS 2000 SP 40M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
18 00850951007432 TIMS 500 40M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
19 00850951007425 TIMS 2000 EN 39M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
20 00850951007340 TIMS 500 36M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
21 00850951007418 TIMS 2000 SP 39M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
22 00850951007401 TIMS 500 39M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
23 00850951007395 TIMS 2000 EN 37M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
24 00850951007388 TIMS 2000 SP 37M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
25 00850951007371 TIMS 500 37M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
26 00850951007364 TIMS 2000 SP 36M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
27 00850951007357 TIMS 2000 EN 36M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
28 00850951007333 TIMS 2000 SP 32M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
29 00850951007326 TIMS 2000 32M 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
30 00850951007319 TIMS 500 32M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
31 00850951007302 TIMS 2000 SP 35M 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
32 00850951007296 TIMS 2000 EN 35M 061000-2000-EN TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
33 00850951007289 TIMS 500 35M 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
34 00850951007272 TIMS OEM Rev L 061000-OEM-CPU-HD+C TIMS System connects to all analog and digital modalities. Usage includes video TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
35 00850951007265 TIMS Streamer 1B 072000-100 TIMS Streamer transmits any live medical modality video over networks - LAN, WAN TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures. LLZ System, Image Processing, Radiological 2 TIMS System
36 00850951007258 TIMS 2000 SP 32L 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
37 00850951007241 TIMS 2000 32L 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
38 00850951007234 TIMS 500 32L 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
39 00850951007227 TIMS 500 31K 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
40 00850951007210 TIMS 2000 31K 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
41 00850951007203 TIMS 2000 SP 31K 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
42 00850951007180 TIMS 2000 30K 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
43 00850951007173 TIMS 500 30K 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
44 00850951007166 TIMS 500 29K 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
45 00850951007159 TIMS 2000 29K 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
46 00850951007142 TIMS 2000 SP 29K 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
47 00850951007135 TIMS 2000 SP 28K 061000-2000-SP TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
48 00850951007128 TIMS 2000 28K 061000-2000 TIMS 2000 connects to all analog and DICOM medical modalities. Functionality in TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
49 00850951007111 TIMS 500 28K 061000-500 TIMS 500 connects to all analog and DICOM medical modalities. Functionality inc TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. LLZ System, Image Processing, Radiological 2 TIMS System
50 00850951007104 TIMS OEM Rev K 061000-OEM-CPU-HD+C TIMS System connects to all analog and digital modalities. Usage includes video TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning. LLZ System, Image Processing, Radiological 2 TIMS System
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14 07350092810432 16.2 Sectra Orthopaedic Package is intended to assist the user when doing preoperativ Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists. Sectra Orthopedic Package SECTRA AB
15 07350092810418 24.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
16 07350092810401 16.1 Sectra Orthopaedic Package is intended to assist the user when doing preoperativ Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists. Sectra Orthopedic Package SECTRA AB
17 07350092810371 24.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
18 07350092810364 15.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
19 07350092810357 23.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
20 07350092810326 23.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
21 07350092810296 14.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
22 07350092810265 22.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
23 07350092810258 14.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
24 07350092810234 21.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
25 07350092810227 12.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
26 07350092810210 22.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
27 07350092810180 21.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
28 07350092810173 12.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
29 07350092810166 21.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
30 07350092810159 20.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
31 07350092810111 11.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
32 07350092810098 20.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. Sectra Workstation SECTRA AB
33 07350092810081 11.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
34 07350092810074 20.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
35 07350092810067 19.2 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
36 07350092810050 19.3 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
37 07350092810043 10.1 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
38 07350092810036 19.1 Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.In the United States only:- Mammographic images must be reviewed on a monitor approved by FDA for mammographic images- The Sectra Workstation is not intended for primary diagnosis of digital pathology images.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast). Sectra Workstation SECTRA AB
39 07350092810029 9.2 Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up.The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images. Sectra Orthopedic Package SECTRA AB
40 07350092810012 18.2 Sectra Workstation is intended for the display and manipulation of medical image Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from different sources and interface with various image storage and printing devices using DICOM and similar interface standards.Areas of application include, e.g., radiology, mammography, pathology, orthopedic preoperative planning and postoperative follow-up.Lossy compressed mammographic images are not intended for diagnostic review. For primary diagnosis, post-process DICOM “for presentation” images should be used.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Sectra Workstation IDS7 SECTRA AB
41 07350010100027 2 Software for cardiac image analysis. Segment CMR MEDVISO AB
42 07350010100010 2 Software for medical image analysis. Segment MEDVISO AB
43 07350002336021 02 602 PYLARIFY AI is intended to be used by healthcare professionals and researchers f PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. PYLARIFY AI EXINI DIAGNOSTICS AB
44 07350002336014 01 601 PYLARIFY AI is a software only medical device that provides quantitative assessm PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. PYLARIFY AI EXINI DIAGNOSTICS AB
45 07350002335017 01 501 aPROMISE is a softwareonly medical device that provides quantitative assessments aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. aPROMISE EXINI DIAGNOSTICS AB
46 07350002332030 03 203 The aBSI is a software-only medical device that provides a fully quantitative as The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results. aBSI EXINI DIAGNOSTICS AB
47 07350002331033 3 103 EXINI is intended to be used by trained health-care professionals and researcher EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer,storage, image display, manipulation, quantification and reporting of digital medical images. The system isintended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). Thesoftware provides general Picture Archiving and Communications System (PACS) tools and a clinical applicationfor oncology including lesion marking and analysis. EXINI EXINI DIAGNOSTICS AB
48 07340201500040 AATMA AATMA ELEKTA SOLUTIONS AB
49 07332747199802 3.2_L 300851 DTX Studio Clinic 3.2 for Win 64-bit limited DTX Studio™ Clinic NOBEL BIOCARE AB
50 07332747199796 3.2_L 300851 DTX Studio Clinic 3.2 for Mac limited DTX Studio™ Clinic NOBEL BIOCARE AB