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Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.2
Not in Commercial Distribution
- 03700719700396 ()
- Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.1
Not in Commercial Distribution
- 03700719700013 ()
- Radiological PACS software
QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution
- B80731 ()
3
- Radiological PACS software
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution
- B80721 ()
2
- Radiological PACS software
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution
- B80711 ()
1
- Radiological PACS software
ACO Planner
Materialise NV
ACO Planner
Not in Commercial Distribution
- E314ACOPLANNER0 ()
ACO Planner
- CAD/CAM software
Zimmer PSIP
Materialise NV
Zimmer PSIP
Not in Commercial Distribution
- E314ZIMMERPSIP0 ()
Zimmer PSIP
- CAD/CAM software
Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution
- E314ZIMMERPSIOMS0 ()
Zimmer online management system
- CAD/CAM software
SurgiCase Viewer
Materialise NV
SurgiCase Viewer
In Commercial Distribution
- E314SURGICASEVIEWER0 ()
SurgiCase Viewer
- CAD/CAM software
SurgiCase Transfer
Materialise NV
SurgiCase Transfer
In Commercial Distribution
- E314SURGICASETRANSFER0 ()
SurgiCase Transfer
- CAD/CAM software