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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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Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution

  • B2551143 ()
1143

  • Clinical information system web-based application software
Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution

  • B2551125 ()
1125

  • Clinical information system web-based application software
Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution

  • B2551120 ()
1120

  • Clinical information system web-based application software
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 v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software
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
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
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
No Description
Visage Imaging GmbH
1.0
In Commercial Distribution

  • 04251332930008 ()


  • Radiological PACS software
No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution

  • 04056869985947 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution

  • 04056869975559 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431590
In Commercial Distribution

  • 04056869975535 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431567
In Commercial Distribution

  • 04056869975528 ()


  • SPECT system application software
  • PET system application software
No Description
Siemens Healthcare GmbH
11665399
In Commercial Distribution

  • 04056869968278 ()


  • Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11582982
In Commercial Distribution

  • 04056869298207 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431553
In Commercial Distribution

  • 04056869279800 ()


  • SPECT system application software
  • PET system application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11545289
In Commercial Distribution

  • 04056869274638 ()


  • Radiology DICOM image processing application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11294432
Not in Commercial Distribution

  • 04056869257952 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA2
In Commercial Distribution

  • 04056869952574 ()


  • PET system application software
  • SPECT system application software
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