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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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Blackford Dashboard - 05060570830082

Blackford Dashboard v1.2, monitoring tool for users of the Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830082 ()


  • Radiological PACS software

Blackford Smart Localizer - 05060570830075

Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830075 ()


  • Radiological PACS software

Blackford Platform - 05060570830068

Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.2.x
In Commercial Distribution

  • 05060570830068 ()


  • Radiological PACS software

Blackford Registration Application - 05060570830044

Blackford Registration Application v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830044 ()


  • Radiological PACS software

Blackford Platform - 05060570830037

Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.1.x
In Commercial Distribution

  • 05060570830037 ()


  • Radiological PACS software

Blackford Registration Application - 05060570830013

Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830013 ()


  • Radiological PACS software

Blackford Platform - 05060570830006

Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution

  • 05060570830006 ()


  • Radiological PACS software

AIRAscore - 04260723680040

AIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
AIRAmed GmbH
v2.4.0
In Commercial Distribution

  • 04260723680040 ()


  • 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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