BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P970058 · Supplement: S012 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    IMAGECHECKER M1000
    PMA Number
    P970058
    Supplement Number
    S012
    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
    February 11, 2002
    Date Received
    February 5, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE NEW EFFICACY CLAIM IN PMA SUPPLEMENT 7 (VERSION 2.2 SOFTWARE). THE CHANGE IS FROM: "FOR EVERY 100,000 CANCERS CURRENTLY DETECTED BY SCREENING MAMMOGRAPHY, THE USE OF THE IMAGECHECKER COULD RESULT IN EARLY DETECTION OF AN ADDITIONAL 30,500 BREAST CANCERS." TO: "USE OF THE IMAGECHECKER COULD RESULT IN EARLIER DETECTION OF UP TO 23.4% (95% CI, 19.4% - 27.4%) OF THE CANCERS CURRENTLY DETECTED WITH SCREENING MAMMOGRAPHY IN THOSE WOMEN WHO HAD A PRIOR SCREENING MAMMOGRAM 9-24 MONTHS EARLIER."

    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