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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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Viz ICH+ - 00811852030349

Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution

  • 00811852030349 ()


  • Radiology DICOM image processing application software

Viz HCM - 00811852030332

Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software

Viz RV/LV - 00811852030295

Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution

  • 00811852030295 ()


  • Radiology DICOM image processing application software

FUJIFILM - 04547410541199

This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software

MI View&GO - 04068151027013

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software

Scenium - 04068151009477

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software

Visage Breast Density - 04251332930008

No Description
Visage Imaging GmbH
1.0
In Commercial Distribution

  • 04251332930008 ()


  • Radiological PACS software

Syngo Carbon Clinicals - 04056869985947

No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution

  • 04056869985947 ()


  • Radiology DICOM image processing application software

Scenium - 04056869975559

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution

  • 04056869975559 ()


  • PET system application software
  • SPECT system application software

syngo.MI General - 04056869975535

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431590
In Commercial Distribution

  • 04056869975535 ()


  • SPECT system application software
  • PET system application software
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