BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P010034 · Supplement: S001 · Decision May 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
    PMA Number
    P010034
    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
    May 7, 2002
    Date Received
    March 4, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN OVERALL UPGRADE TO THE HARDWARE AND SOFTWARE IN THE DEVICE. THESE CHANGES IMPROVED THE SENSITIVITY, DECREASED THE MARKS PER CASE AND MADE AN IMPROVEMENT IN FALSE NEGATIVES. IN ADDITION, SOFT-COPY, INCREASED STORAGE, AND DICOM INTERFACING WERE ADDED ALONG WITH SUNDRY OTHER OPERATING IMPROVEMENTS.

    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