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510(k) Data Aggregation

    K Number
    K191959
    Device Name
    QuantX Breast MRI Biopsy Guidance Plugin
    Manufacturer
    Date Cleared
    2019-11-08

    (108 days)

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

    Qlarity Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
    Device Description
    The QuantX Breast MRI Biopsy Guidance Plugin assists users in planning MRI quided interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. Its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. The QuantX Breast MRI Biopsy Guidance Plugin may be used in either the SE or Advanced version of QuantX, a software program used for the display and analysis of medical images.
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