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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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myVisionTrack - 00860003376157

Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software

myVisionTrack - 00860003376119

Vision testing application - HCP Portal
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376119 ()


  • Vision self-testing software

myVisionTrack - 00860003376102

Vision testing application - android version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376102 ()


  • Vision self-testing software

Cleerly Ischemia - 00860001924121

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia.
CLEERLY, INC.
v1.0
In Commercial Distribution

  • 00860001924121 ()


  • Radiological PACS software

Cleerly Labs - 00860001924114

Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.
CLEERLY, INC.
v2.0
In Commercial Distribution

  • 00860001924114 ()


  • Radiological PACS software

Movive Education Unit - 00860001790832

Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution

  • 00860001790832 ()


  • Neuromuscular rehabilitation software

InTandem Education Unit - 00860001790825

Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution

  • 00860001790825 ()


  • Neuromuscular rehabilitation software

Movive - 00860001790818

Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is intended to be used in the home for the physical rehabilitation of ambulatory adults with walking impairments from Parkinson's disease.
Medrhythms, Inc.
0050
In Commercial Distribution

  • 00860001790818 ()


  • Neuromuscular rehabilitation software

InTandem - 00860001790801

InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution

  • 00860001790801 ()


  • Neuromuscular rehabilitation software

UltraMANAGEMENT UTILITY - 00860001148596

UltraRAD Product User Web Interface
ULTRARAD CORPORATION
2.0.2.8
In Commercial Distribution



  • Radiological PACS software
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