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510(k) Data Aggregation

    K Number
    K173605
    Device Name
    iQMR
    Date Cleared
    2018-03-08

    (107 days)

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

    Medic Vision - Imaging Solutions Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.
    Device Description
    iQMR is a software package that is aimed to process MRI images. The iQMR processing enhances MRI images by reduction of the image noise. The software runs on a PC server, which is connected to the Local Area Network (LAN). The device receives MRI images from different work stations over the network in DICOM format, processes the images and transmits them in DICOM format, to selected work stations.
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