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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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AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray 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
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
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
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
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