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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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Disposable snap that snaps onto a Jamshidi for instrument tracking.
TrackX Technology, LLC
HANG-TEN SNAP
Not in Commercial Distribution

  • 00860099000899 ()
  • 00860099000882 ()
TX-3-3070

  • Diagnostic x-ray digital imaging system workstation application software
TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking. Instrument Tracker .125 IN (previously known as Snap 2 or 12)
TrackX Technology, LLC
T SNAP
Not in Commercial Distribution

  • 00860099000813 ()
  • 00860099000875 ()
TX-3-3038

  • Diagnostic x-ray digital imaging system workstation application software
Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution

  • 00860099000806 ()
TX-3-3036

  • Diagnostic x-ray digital imaging system workstation application software
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
In Commercial Distribution

STAR Apollo Mapping System

  • Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution

  • 00860009793507 ()
STAR Apollo Mapping System

  • Cardiac mapping system application software
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution

  • 00860008443717 ()


  • Diagnostic x-ray digital imaging system workstation 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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