BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P970058 · Supplement: S019 · Decision Apr 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
    PMA Number
    P970058
    Supplement Number
    S019
    Device Class
    FDA Class 2
    Product Code
    MYN
    Generic Name
    Analyzer, medical image
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 7, 2004
    Date Received
    March 1, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHIC SYSTEM AND EQUIVALENT PRIVATE LABEL DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER M5000D (DIGITAL MAMMOGRAPHY ONLY) AND IMAGECHECKER M5000DM (DIGITAL AND ANALOG MAMMOGRAPHY). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.2. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER M5000D/DM IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYN Analyzer, Medical Image