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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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suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution

  • 00850001088008 ()


  • MRI system application software
U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 00847865001281 ()

  • 1 Each
665-3465A

  • Laboratory instrument/analyser application software IVD
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170328985 ()


  • Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2528
In Commercial Distribution

  • 04953170435201 ()


  • Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2258
Not in Commercial Distribution

  • 04953170390616 ()


  • Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2139
Not in Commercial Distribution

  • 04953170363016 ()


  • Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2370
In Commercial Distribution

  • 04953170406461 ()


  • Operating room audiovisual data/device management system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2088
Not in Commercial Distribution

  • 04953170352881 ()


  • Operating room audiovisual data/device management system application software
No Description
KONAN MEDICAL, INC.
CellChek 20-1 PLUS
In Commercial Distribution

  • 04582275250671 ()


  • Eye anterior segment analyser
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