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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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uWS - 06971576834143

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834143 ()


  • MRI system application software

HeartPro - 17540266000029

HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.6
Not in Commercial Distribution

  • 17540266000029 ()


  • MRI system application software

HeartPro - 17540266000012

HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.5
Not in Commercial Distribution

  • 17540266000012 ()


  • MRI system application software

Thermoguide Workstation - 17340007000833

No Description
Clinical Laserthermia Systems AB
1100-N1
In Commercial Distribution

  • 17340007000833 ()


  • MRI system application software

DIGITAL DIAGNOSTICS SYSTEM - 15420045513914

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045513914 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD

MULTIVIEW - 15420045504684

MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD

SecurView Diagnostic Workstation - 15420045504523

The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis.
Hologic, Inc.
SecurView DX
In Commercial Distribution

  • 15420045504523 ()


  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683252

NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683252 ()
B91238

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683245

NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683245 ()
B91237

  • Laboratory instrument/analyser application software IVD
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