Other products from "MINXRAY, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00858846007253 TR90BH The TR90BH is a portable X-ray system with following limitations of use: The de The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. IZL System, X-Ray, Mobile 2 MinXray
2 00858846007246 HFP24 Podiatric X-ray unit This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a podiatric mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors IZL System, X-Ray, Mobile 2 MinXray
3 00858846007239 HFP40 Portable X-ray unit This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors. IZL System, X-Ray, Mobile 2 MinXray
4 00858846007222 CMDR.TW.1202.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
5 00858846007215 CMDR.PE.1202.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
6 00858846007208 CMDR.PE.120.60.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
7 00858846007192 CMDR.TW.120.60.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
8 00858846007185 CMDR.PE.100.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
9 00858846007178 Integris This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
10 00858846007161 CMDR.PE.120.60.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
11 00858846007154 CMDR.TW.120.60.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
12 00858846007147 CMDR.T.100.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
13 00858846007130 CMDR.TW.100.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
14 00858846007123 CMDR.TW.1202.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
15 00858846007116 CMDR.T.1202.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
16 00858846007109 CMDR.T.1202.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
17 00858846007093 CMDR.TW.100.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
18 00858846007086 CMDR.T.100.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
19 00858846007079 CMDR.PE.1202.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
20 00858846007062 CMDR.PE.100.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
21 00858846007055 CMDR.T.120.60.S This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
22 00858846007048 CMDR.T.120.60.R This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. LLZ,MQB,IZL System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digi System, Image Processing, Radiological,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Mobile 2 MinXray
23 00858846007024 HF120/60HPPWV PowerPlus Portable X-ray This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors IZL System, X-Ray, Mobile 2 MinXray
24 00858846007017 HF100H+ Portable X-ray This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors IZL System, X-Ray, Mobile 2 MinXray
25 00858846007000 HF1202H Portable X-ray This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors IZL System, X-Ray, Mobile 2 MinXray
Other products with the same Product Codes "LLZ, MQB, IZL"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07540263000025 3.0 The VMS+ system is an adjunct to existing ultrasound imaging systems and is inte The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired. Ventripoint Medical System Plus (VMS+) VENTRIPOINT DIAGNOSTICS LTD
2 07540201000247 Size 2 Replacement (A-Series) 6101AR Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR Tuxedo LED DENTAL INC
3 07540201000230 Size 1 Replacement (A-Series) 6100AR Tuxedo Intraoral Sensor Size 1 (6100A Replacement) PN 6100AR Tuxedo LED DENTAL INC
4 07540201000223 Size 2 Replacement 6101R Tuxedo Intraoral Sensor Size 2 (6101 Replacement) PN 6101R Tuxedo LED DENTAL INC
5 07540201000216 Size 1 Replacement 6100R Tuxedo Intraoral Sensor Size 1 (6100 Replacement) Tuxedo LED DENTAL INC
6 07540201000070 Size 2 6101, 6101A Tuxedo LED DENTAL INC
7 07540201000063 Size 1 6100, 6100A Tuxedo LED DENTAL INC
8 07392532209413 Version 3.1 54500395IV31 Case Viewer Simplant DENTSPLY IMPLANTS NV
9 07392532208423 Version 3.1 54500394E31 Simplant Editor Simplant DENTSPLY IMPLANTS NV
10 07392532208416 Version 18.5 54500277V185 Simplant View Simplant DENTSPLY IMPLANTS NV
11 07392532206269 Version 18.5 54500277P185 Simplant Pro Simplant DENTSPLY IMPLANTS NV
12 07392532205583 Version 3 54500395IV3 Case Viewer Simplant DENTSPLY IMPLANTS NV
13 07392532204814 Version 3 54500394E3 Simplant Editor Simplant DENTSPLY IMPLANTS NV
14 07392532191251 Version 18 54500277P18 Simplant Pro Simplant DENTSPLY IMPLANTS NV
15 07392532191237 Version 18 54500277O18 Simplant OneShot Simplant DENTSPLY IH, INC.
16 07392532191220 Version 18 54500277V18 Simplant View Simplant DENTSPLY IMPLANTS NV
17 07392532181276 Version 2 54500395IV SIMPLANT Viewer SIMPLANT® DENTSPLY IMPLANTS NV
18 07392532181252 Version 2 54500394E2 SIMPLANT Editor SIMPLANT® DENTSPLY IMPLANTS NV
19 07392532178030 Version 17 54500277A SIMPLANT Pro SIMPLANT® DENTSPLY IMPLANTS NV
20 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
21 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
22 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
23 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 07350010100027 2 Software for cardiac image analysis. Segment CMR MEDVISO AB
48 07350010100010 2 Software for medical image analysis. Segment MEDVISO AB
49 07350008750050 0180 Stationary x-ray system intended for obtaining radiographic images of various po Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography. OMNERA 400T ARCOMA AB
50 07350008750012 0072 Stationary x-ray system intended for obtaining radiographic images portions of t Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography. OMNERA 400A ARCOMA AB