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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 Class Implantable

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Visage 7 - 04251332910024

No Description
Visage Imaging GmbH
7.1.11
In Commercial Distribution

  • 04251332910024 ()


  • Radiological PACS software

Visage 7 - 04251332910017

No Description
Visage Imaging GmbH
7.1.10
In Commercial Distribution

  • 04251332910017 ()


  • Radiological PACS software

Visage 7 - 04251332910000

No Description
Visage Imaging GmbH
7.1.9
In Commercial Distribution

  • 04251332910000 ()


  • Radiological PACS software

Volpara Scorecard - 09421904268333

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.5
In Commercial Distribution

  • 09421904268333 ()


  • Radiological PACS software

Volpara Density Map - 09421904268319

Volpara Density Map 4.0
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268319 ()


  • Radiological PACS software

Volpara Density Map - 09421904268289

Volpara Density Map 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268289 ()


  • Radiological PACS software

VolparaDensity - 09421904268258

VolparaDensity 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268258 ()


  • Radiological PACS software

VolparaDensity - 09421904268241

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268241 ()


  • Radiological PACS software

JiveX - 04260632470084

Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
VISUS Health IT GmbH
5.4+
In Commercial Distribution

  • 04260632470084 ()


  • Radiological PACS software

JiveX - 04260632470039

Version 5.3 includes all minor versions and patch levels of 5.3
VISUS Health IT GmbH
5.3
Not in Commercial Distribution

  • 04260632470039 ()


  • Radiological PACS software
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