BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P970058 · Supplement: S018 · Decision Nov 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)
    PMA Number
    P970058
    Supplement Number
    S018
    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
    November 26, 2003
    Date Received
    October 22, 2003
    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 FISCHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER D (DIGITAL MAMMOGRAPHY ONLY), IMAGECHECKER DM (DIGITAL AND ANALOG MAMMOGRAPHY), AND IMAGECHECKER OEM-D (DIGITAL MAMMOGRAPHY ONLY, SOLD BY FFDM VENDOR). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.1. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER D/DM.OEM-D 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