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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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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

DIGITAL DIAGNOSTICS SYSTEM - 15420045514201

Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Hologic, Inc.
DISPLAY, 27IN, 8MP
In Commercial Distribution

  • 15420045514201 ()
CMP-01669

  • Laboratory instrument/analyser application software IVD

uWS - 06971576834143

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

  • 06971576834143 ()


  • MRI system application software

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

reticONE - 15099590572686

reticONE System
Beckman Coulter, Inc.
6915048
In Commercial Distribution

  • 15099590572686 ()
6915048

  • Laboratory instrument/analyser application software IVD

tetraCXP SW - 15099590547240

tetraCXP System
Beckman Coulter, Inc.
629638
In Commercial Distribution

  • 15099590547240 ()
629638

  • Laboratory instrument/analyser application software IVD

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

ThinPrep Imaging System - 15420045512535

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD
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