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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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 2.1
Not in Commercial Distribution

  • 03700719700013 ()


  • Radiological PACS 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
SurgiCase Shoulder Planner
Materialise NV
SurgiCase Shoulder Planner
In Commercial Distribution

  • E314SURGICASESHOULPLAN0 ()
SurgiCase Shoulder Planner

  • CAD/CAM software
SurgiCase Planner
Materialise NV
SurgiCase Planner
Not in Commercial Distribution

  • E314SURGICASEPLANNER0 ()
SurgiCase Planner

  • CAD/CAM software
SurgiCase OOS
Materialise NV
SurgiCase OOS
In Commercial Distribution

  • E314SURGICASEOOS0 ()
SurgiCase OOS

  • CAD/CAM software
SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
SurgiCase Knee Planner
Materialise NV
SurgiCase Knee Planner
In Commercial Distribution

  • E314SURGICASEKNEEPLAN0 ()
SurgiCase Knee Planner

  • CAD/CAM software
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