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510(k) Data Aggregation

    K Number
    K113284
    Device Name
    BIOPSY POSITIONER
    Manufacturer
    FUJI FILM MEDICAL SYSTEMS
    Date Cleared
    2012-03-07

    (121 days)

    Product Code
    IZH, BIO
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJI FILM MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUJIFILM Biopsy Positioner (FDR-1000BPY) is an optional accessory for the Aspire HD (FDR MS-1000) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).
    Device Description
    The FUJIFILM Biopsy Positioner is an optional accessory for the Aspire HD (FDR MS-1000) full field digital mammography system and future Fujifilm digital mammography exposure stands. It is designed for positioning the needle when performing stereotactic biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a stereo pair of images, taken with the tube arm angled to +1 5° from vertical (orthogonal to the plane of the image receptor). The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the two images, as indicated by the operator, and the known geometry of the system. The Biopsy Positioner is composed of the following elements: - The Positioner that supports and positions the needle . - The Operation panel which displays the distance between the compression plate and target ● pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions. - The Positioner Control Unit which supplies power to the positioner
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