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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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Merge OrthoPACS - 00842000100676

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100676 ()


  • Radiological PACS software

eFilm Workstation - 00842000100652

No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100652 ()


  • Radiological PACS software

Merge PACS - 00842000100478

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100478 ()


  • Radiological PACS software

Merge Unity Pacs - 00842000100461

No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100461 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100454

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100454 ()


  • Radiological PACS software

eFilm Lite - 00842000100300

No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100300 ()


  • Radiological PACS software

Merge Eye Station - 00842000100140

No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.6.1
Not in Commercial Distribution

  • 00842000100140 ()


  • Radiological PACS software

iConnect Enterprise Workflow with Merge PACS - 00842000100133

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.
MERGE HEALTHCARE SOLUTIONS INC.
1.0
In Commercial Distribution

  • 00842000100133 ()


  • 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
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