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510(k) Data Aggregation

    K Number
    K211356
    Device Name
    GIQuant
    Manufacturer
    Date Cleared
    2021-11-08

    (189 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Motilent Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GIQuant is a post-processing software into existing medical imaging workflows that is intended to derive motion related parameters from abdominal data obtained during magnetic resonance imaging (MRI). GIQuant is designed to aid trained physicians in advanced image assessment, treatment consideration, and monitoring of therapeutic response. The information provided by GIQuant should not be used in isolation when making patient management decisions.
    Device Description
    GIQuant is a standalone software medical imaging post processing application that runs on standard computer hardware. GIQuant performs numerical analysis and generates image parameter maps, based on DICOM images captured via Magnetic Resonance Imaging. These actions include: - Receipt of MR DICOM image studies from DICOM storage and communication devices. - Registration of images generated at different time points. - Comparison of registered images. - Computation of motility parameter maps based on dynamic abdominal MR imaging data. - Output of the above maps in DICOM format for export to PACS. GIQuant can be deployed within its own image storage and communication infrastructure or alternatively it can be "plugged in" and launched from within other FDA cleared applications.
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