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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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No Description
Epocal Inc
SD-0004-00-00
Not in Commercial Distribution

  • 00809708114572 ()


  • Laboratory instrument/analyser application software IVD
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software
No Description
Clinical Laserthermia Systems AB
1100-N1
In Commercial Distribution

  • 17340007000833 ()


  • MRI system application software
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 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
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
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834143 ()


  • MRI system application software
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 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 System
Beckman Coulter, Inc.
6915048
In Commercial Distribution

  • 15099590572686 ()
6915048

  • Laboratory instrument/analyser application software IVD
tetraCXP System
Beckman Coulter, Inc.
629638
In Commercial Distribution

  • 15099590547240 ()
629638

  • Laboratory instrument/analyser application software IVD
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
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
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD
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
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
Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504097 ()
ASY-06281

  • Laboratory instrument/analyser application software IVD
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