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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
3-matic Medical
Materialise NV
3-matic Medical
In Commercial Distribution

  • E3143MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM 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
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