Other products from "CARESTREAM DENTAL LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 60192156559852 CS 1500 6559850 CS1500 HAND PIECE WIRELESS EIA Unit, Operative Dental 1 CS 1500
2 60192156559814 CS 1500 6559819 CS1500 INTRA ORAL CAMERA WIRED USB EIA Unit, Operative Dental 1 CS 1500
3 60192156559807 CS 1500 6559801 CS1500 INTRA ORAL CAMERA WIRELESS EIA Unit, Operative Dental 1 CS 1500
4 60192155943065 5943063 5943063 CS 3800 3D I/O SCANNER WIRELESS NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 2 CS 3800 Wireless
5 60192155942723 CS 7200 5942727 CS 7200 IMAGING PLATE SYSTEM MUH System, X-Ray, Extraoral Source, Digital 2 CS 7200
6 60192155501548 Trophypan Supreme 3D 5501549 Trophypan Supreme 3D OAS X-Ray, Tomography, Computed, Dental 2 Trophypan Supreme 3D
7 60192155313585 CS 8100 Access 5313580 CS 8100 ACCESS MUH System,x-ray,extraoral source,digital 2 CS 8100 Access
8 60192155302886 SINGLE USE SLEEVES - 3D BITE BLOCK 5302880 SINGLE USE SLEEVES - 3D BITE BLOCK KQM CAMERA, SURGICAL AND ACCESSORIES 1 SINGLE USE SLEEVES - 3D BITE BLOCK
9 60192155211010 CEPHALOSTAT 5211016 CEPH UPGRADE FOR 9X00 FAMILY MUH,OAS System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental 2 CEPHALOSTAT
10 60192155944482 5944483 5944483 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY PNN Orthodontic Software 2 CS Model+
11 60192155943218 5943212 5943212 CS 8200 3D MUH,OAS System, X-Ray, Extraoral Source, Digital,X-Ray, Tomography, Computed, Dental 2 CS 8200 3D
12 60192155942716 CS Model+ 5942719 CS MODEL+ PNN Orthodontic Software 2 CS Model+
13 60192155500329 CS 8100 3D Access 5500327 CS 8100 3D ACCESS OAS,MUH X-ray, tomography, computed, dental,System,x-ray,extraoral source,digital 2 CS 8100 3D Access
14 60192155008184 Hygienic Sleeves 3D Bite Block BDA16 PROTECTIONS HYGIENIQUE MORDU 3D CSD KQM CAMERA, SURGICAL AND ACCESSORIES 1 Hygienic Sleeves 3D Bite Block
15 60192155008160 RVG 5100 CIC52 CAPTEUR RVG 5100 T2 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 5100
16 60192155008016 RVG 5100 CIC39 CAPTEUR RVG 5100 T1 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 5100
17 40192155942651 CS 7600 Hygienic Sheath 5942651 CS 7600 HYG SHEATHS SIZE 4 200 PCS KQM Camera, Surgical And Accessories CS 7600 Hygienic Sheath
18 40192155942644 CS 7600 Hygienic Sheath 5942644 CS 7600 HYG SHEATHS SIZE 3 200 PCS KQM Camera, Surgical And Accessories CS 7600 Hygienic Sheath
19 40192155942637 CS 7600 Hygienic Sheath 5942636 CS 7600 HYG SHEATHS SIZE 2 200 PCS KQM Camera, Surgical And Accessories CS 7600 Hygienic Sheath
20 40192155942620 CS 7600 Hygienic Sheath 5942628 CS 7600 HYG SHEATHS SIZE 1 200 PCS KQM Camera, Surgical And Accessories CS 7600 Hygienic Sheath
21 40192155942613 CS 7600 Hygienic Sheath 5942610 CS 7600 HYG SHEATHS SIZE 0 200 PCS KQM Camera, Surgical And Accessories CS 7600 Hygienic Sheath
22 60192155942662 CS 3700 3D I/O SCANNER CARBON GREY 5942669 CS 3700 3D I/O SCANNER CARBON GREY NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 2 CS 3700
23 60192155944543 5944541 5944541 Swissmeda powered by Carestream Dental LLZ System, Image Processing, Radiological 2 Swissmeda powered by Carestream Dental
24 60192155941306 CS 3700 5941307 CS 3700 3D I/O SCANNER ARCTIC WHITE NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 2 CS 3700
25 60192155501197 CS 9600 5501192 CS 9600 OAS X-Ray, Tomography, Computed, Dental 2 CS 9600
26 60192155311307 RVG 5200 5311303 RVG 5200 SIZE 2 EAP UNIT, X-RAY, INTRAORAL 2 RVG 5200
27 60192155311291 RVG 5200 5311295 RVG 5200 SIZE 1 EAP UNIT, X-RAY, INTRAORAL 2 RVG 5200
28 60192155302893 SINGLE USE SLEEVES - EAR RODS 5302898 SINGLE USE SLEEVES - EAR RODS KQM CAMERA, SURGICAL AND ACCESSORIES 1 SINGLE USE SLEEVES - EAR RODS
29 40192155942514 CS 7600 Smart Plate 5942511 CS7600 SMART PLATE SIZE 0 V2 - 4 PCS EAM Screen, Intensifying, Radiographic CS 7600 Smart Plate
30 60192155302879 SINGLE USE SLEEVES - PANO BITE BLOCK 5302872 SINGLE USE SLEEVES - PANO BITE BLOCK KQM CAMERA, SURGICAL AND ACCESSORIES 1 SINGLE USE SLEEVES - PANO BITE BLOCK
31 60192155008191 Hygienic Sleeves Ear Cones BDA17 PROTECTIONS HYGIEN. AURICULAIRE 3D CSD KQM CAMERA, SURGICAL AND ACCESSORIES 1 Hygienic Sleeves Ear Cones
32 60192155008108 RVG 5200 CIC48 CAPTEUR RVG 5200 T2 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 5200
33 60192155008092 RVG 5200 CIC47 CAPTEUR RVG 5200 T1 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 5200
34 60192155008061 RVG 6500 CIC44 CAPTEUR RVG 6500 T0 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 6500
35 60192155008054 RVG 6500 CIC43 CAPTEUR RVG 6500 T2 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 6500
36 60192155008047 RVG 6500 CIC42 CAPTEUR RVG 6500 T1 CSD EAP UNIT, X-RAY, INTRAORAL 2 RVG 6500
37 40192155942569 CS 7600 Smart Plate 5942560 CS7600 SMART PLATE SIZE 4 V2 - 2 PCS EAM Screen, Intensifying, Radiographic CS 7600 Smart Plate
38 40192155942552 CS 7600 Smart Plate 5942552 CS7600 SMART PLATE SIZE 3 V2 - 4 PCS EAM Screen, Intensifying, Radiographic CS 7600 Smart Plate
39 40192155942545 CS 7600 Smart Plate 5942545 CS7600 SMART PLATE SIZE 2 V2 - 4 PCS EAM Screen, Intensifying, Radiographic CS 7600 Smart Plate
40 40192155942538 CS 7600 Smart Plate 5942537 CS7600 SMART PLATE SIZE 1 V2 - 4 PCS EAM Screen, Intensifying, Radiographic CS 7600 Smart Plate
41 60192156851666 CS OMS Imaging Software 1746841 CS OMS Imaging Software LLZ System, image processing, radiological 2 CS OMS Imaging Software
42 60192156851659 CS OMS Imaging Software 1546977 CS OMS Imaging Software LLZ System, image processing, radiological 2 CS OMS Imaging Software
43 60192155500237 CS 8100SC 3D Access 5500236 CS 8100SC 3D ACCESS MUH,OAS System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental 2 CS 8100SC 3D Access
44 60192155319747 CS 9300 Select 5319744 CS 9300 SELECT 110V OAS X-ray, tomography, computed, dental 2 CS 9300 Select
45 60192155319716 CS 9300 Select 5319710 CS 9300 SELECT 230V OAS X-ray, tomography, computed, dental 2 CS 9300 Select
46 60192155319440 RVG CONNECT 5319447 RVG CONNECT FOR US EAP UNIT, X-RAY, INTRAORAL 2 RVG CONNECT
47 60192155313950 RVG CONNECT 5313952 RVG CONNECT EAP UNIT, X-RAY, INTRAORAL 2 RVG CONNECT
48 60192156851628 Logicon Caries Detector 8008690 LOGICON SITE LIC (UP TO 10) W/IWT MYN Analyzer,medical image 2 Logicon Caries Detector
49 60192155943720 5943725 5943725 CS 3800 3D I/O SCANNER WIRED NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 2 CS 3800 Wired
50 60192155942754 Logicon Caries Detector 5942750 CSD LOGICON CARIES DETECTOR MYN Analyzer, Medical Image 2 Logicon Caries Detector
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07392532209413 Version 3.1 54500395IV31 Case Viewer Simplant DENTSPLY IMPLANTS NV
2 07392532208423 Version 3.1 54500394E31 Simplant Editor Simplant DENTSPLY IMPLANTS NV
3 07392532208416 Version 18.5 54500277V185 Simplant View Simplant DENTSPLY IMPLANTS NV
4 07392532206269 Version 18.5 54500277P185 Simplant Pro Simplant DENTSPLY IMPLANTS NV
5 07392532205583 Version 3 54500395IV3 Case Viewer Simplant DENTSPLY IMPLANTS NV
6 07392532204814 Version 3 54500394E3 Simplant Editor Simplant DENTSPLY IMPLANTS NV
7 07392532191251 Version 18 54500277P18 Simplant Pro Simplant DENTSPLY IMPLANTS NV
8 07392532191237 Version 18 54500277O18 Simplant OneShot Simplant DENTSPLY IH, INC.
9 07392532191220 Version 18 54500277V18 Simplant View Simplant DENTSPLY IMPLANTS NV
10 07392532181276 Version 2 54500395IV SIMPLANT Viewer SIMPLANT® DENTSPLY IMPLANTS NV
11 07392532181252 Version 2 54500394E2 SIMPLANT Editor SIMPLANT® DENTSPLY IMPLANTS NV
12 07392532178030 Version 17 54500277A SIMPLANT Pro SIMPLANT® DENTSPLY IMPLANTS NV
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 07350010100027 2 Software for cardiac image analysis. Segment CMR MEDVISO AB
41 07350010100010 2 Software for medical image analysis. Segment MEDVISO AB
42 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
43 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
44 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
45 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
46 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
47 07340201500040 AATMA AATMA ELEKTA SOLUTIONS AB
48 07332747199802 3.2_L 300851 DTX Studio Clinic 3.2 for Win 64-bit limited DTX Studio™ Clinic NOBEL BIOCARE AB
49 07332747199796 3.2_L 300851 DTX Studio Clinic 3.2 for Mac limited DTX Studio™ Clinic NOBEL BIOCARE AB
50 07332747197525 2.4 300011 IPS CaseDesigner 2.4 for Windows 64-bit IPS CaseDesigner® NOBEL BIOCARE AB