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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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WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software
WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software
WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software
The ClinicalAccess®, Pro Connect is a feature rich medical station designed to enhance efficiency and patient care in healthcare settings. The Pro Connect comes equipped with dual 22" monitors, ClearCam® PTZ with 12x optical zoom, Jabra conferencing microphone and speaker, integrated small form factor PC, and lockable device storage.
Globalmed Holdings, LLC
1.0
In Commercial Distribution

  • 00850033167221 ()
1CAP001-C01 / 1CAP001-C02

  • Medical image management system
Telemedicine Station with Ergonomic User and Storage Features
Globalmed Holdings, LLC
GMR12150000
In Commercial Distribution

  • 00850033167085 ()
GMR12150000

  • Medical image management system
Mobile Telemedicine Station with Ergonomic User and Storage Features.
Globalmed Holdings, LLC
1CAS004
In Commercial Distribution

  • 00850033167061 ()
1CAS004

  • Medical image management system
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software
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