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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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WorkstationOne™ - B148WSONE1890

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.9
In Commercial Distribution

  • B148WSONE1890 ()


  • Radiology picture archiving and communication system workstation

WorkstationOne™ - B148WSONE1880

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.8
In Commercial Distribution

  • B148WSONE1880 ()


  • Radiology picture archiving and communication system workstation

EEGer4 - B258EEGER4

Neurofeedback Software
EEG SOFTWARE LLC
4
In Commercial Distribution

  • B258EEGER4 ()


  • Biofeedback system application software

My Dose Coach - 04030685900018

Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software

VT1 - 03760253450577

No Description
FIM MEDICAL
Software
In Commercial Distribution

  • 03760253450577 ()


  • Pulmonary function analysis system, adult

LiRAS for LiPA HCV v1 - 05414470156870

No Description
Fujirebio Europe
15687
In Commercial Distribution

  • 05414470156870 ()


  • Laboratory instrument/analyser application software IVD

CapsoView - 00867770000216

Software
CAPSOVISION, INC.
3
In Commercial Distribution

  • 00867770000216 ()
2759

  • Video capsule endoscopy system application software

MyoVision Software - 00853818007477

Software
PRECISION BIOMETRICS INC
Feature Pack H
In Commercial Distribution

  • 00853818007477 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007392

Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution

  • 00853818007392 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007101

Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution

  • 00853818007101 ()


  • Bioelectrical signal analysis software
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