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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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proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at home and required to be used in a quiet environment. This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution

  • 00860006184902 ()


  • Home uroflowmetry software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586349 ()


  • Radiological PACS software
No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


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

  • 00860003376119 ()


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

  • 00860003376102 ()


  • Vision self-testing software
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 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
Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution

  • 00860001790832 ()


  • Neuromuscular rehabilitation software
Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution

  • 00860001790825 ()


  • Neuromuscular rehabilitation software
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