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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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DTX Studio™ Clinic - 07332747196344

DTX Studio Clinic 3.1 for Mac
Nobel Biocare AB
3.1
In Commercial Distribution

  • 07332747196344 ()
300851

  • Radiology DICOM image processing application software

Radmedix AccuVue+ - 00810035220379

A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


  • Radiology DICOM image processing application software

ImageChecker CAD 10.0 - 15420045500037

ImageChecker® computer-aided detection is a software application intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed.
Hologic, Inc.
10.0
In Commercial Distribution

  • 15420045500037 ()
R2LIC-2111

  • Radiology DICOM image processing application software

uWS - 06971576834150

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834150 ()


  • Radiology DICOM image processing application software

DigitalNow HD - 15420045504806

R2 DigitalNow®
Hologic, Inc.
1.0
Not in Commercial Distribution

  • 15420045504806 ()
R2LIC-2104

  • Radiology DICOM image processing application software

Quantra - 15420045504790

Quantra® is a software application intended to calculate the volumetric breast density.
Hologic, Inc.
2.1
In Commercial Distribution

  • 15420045504790 ()
R2LIC-2103-5

  • Radiology DICOM image processing application software

Quantra - 15420045510319

Quantra® is a software application intended to calculate the volumetric breast density.
Hologic, Inc.
2.2
In Commercial Distribution

  • 15420045510319 ()
R2LIC-2103-V2.2

  • Radiology DICOM image processing application software

Cenova - 15420045507395

Cenova™ image analytics server is a high-performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images.
Hologic, Inc.
Cenova Server
Not in Commercial Distribution

  • 15420045507395 ()
SW-06075

  • Radiology DICOM image processing application software

Cenova - 15420045515369

No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515369 ()


  • Radiology DICOM image processing application software

Cenova - 15420045515345

No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515345 ()


  • Radiology DICOM image processing application software
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