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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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Mimics Enlight Medical
Materialise NV
Mimics Enlight Medical
In Commercial Distribution

  • E314MIMICSENLIGHTMED0 ()
Mimics Enlight Medical

  • CAD/CAM software
Mimics Automatic Algorithms Knee MRI
Materialise NV
Knee MRI
In Commercial Distribution

  • E314MIMICSAAKNEEMRI0 ()
Knee MRI

  • CAD/CAM software
Mimics Automatic Algorithms Knee CT
Materialise NV
Knee CT
In Commercial Distribution

  • E314MIMICSAAKNEECT0 ()
Knee CT

  • CAD/CAM software
Mimics Automatic Algorithms Heart CT
Materialise NV
Heart CT
In Commercial Distribution

  • E314MIMICSAAHEARTCT0 ()
Heart CT

  • CAD/CAM software
Mimics Automatic Algorithms CMF CT
Materialise NV
CMF CT
Not in Commercial Distribution

  • E314MIMICSAACMFCT0 ()
CMF CT

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

  • E314ACOPLANNER0 ()
ACO Planner

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
In Commercial Distribution

  • E3143MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
Not in Commercial Distribution

  • E31433MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. 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 radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use.
INTRASENSE
MYRIAN 2.9
In Commercial Distribution

  • 03700719700471 ()


  • 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 2.7.6
Not in Commercial Distribution

  • 03700719700464 ()


  • Radiological PACS software
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