BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P010038 · Supplement: S001 · Decision Feb 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    ICAD
    PMA Number
    P010038
    Supplement Number
    S001
    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 24, 2003
    Date Received
    October 28, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE. THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM. THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED.

    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