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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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Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor
Viz CTP v1.14 (2025-04-06)
VIZ.AI, INC.
Viz CTP Software
In Commercial Distribution



  • Radiology DICOM image processing application software
No Description
LIGHTLAB IMAGING, INC.
D.2 Software
In Commercial Distribution

  • 00812059021338 ()
C408660

  • Coronary optical coherence tomography system
No Description
Hologic, Inc.
I-View 2.0 Software
In Commercial Distribution

  • 15420045512665 ()
SW-05943

  • Stationary mammographic x-ray system, digital
AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
4.3
Not in Commercial Distribution

  • 04250802900404 ()
SW1000

  • Basic diagnostic x-ray system application software
  • Radiology DICOM image processing application software
  • Diagnostic x-ray digital imaging system workstation application software
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
8
In Commercial Distribution

  • 04250802900015 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
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