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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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HipCheck - 07613327459081

No Description
STRYKER CORPORATION
01030300
In Commercial Distribution

  • 07613327459081 ()
0103-0300

  • Radiology DICOM image processing application software

HipMap Femoroacetabular Impingement Analysis - 07613327382570

No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution

  • 07613327382570 ()
3105001000

  • Radiology DICOM image processing application software

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 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

Syngo Carbon Clinicals - 04056869985947

No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution

  • 04056869985947 ()


  • Radiology DICOM image processing application software

AI-Rad Companion Brain MR - 04056869968278

No Description
Siemens Healthcare GmbH
11665399
In Commercial Distribution

  • 04056869968278 ()


  • Radiology DICOM image processing application software

AI-Rad Companion Brain MR - 04056869298207

No Description
Siemens Healthcare GmbH
11582982
In Commercial Distribution

  • 04056869298207 ()


  • Radiology DICOM image processing application software

Ai-Rad Companion Prostate MR - 04056869274638

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 - 04056869257952

AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11294432
Not in Commercial Distribution

  • 04056869257952 ()


  • Radiology DICOM image processing application software

ClariSIGMAM - 08800046800013

ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
ClariPI Inc.
1.1.7
In Commercial Distribution

  • 08800046800013 ()


  • Radiology DICOM image processing application software
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