BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P970058 · Supplement: S016 · Decision Sep 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    IMAGE CHECKER M1000 SYSTEM
    PMA Number
    P970058
    Supplement Number
    S016
    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
    September 10, 2003
    Date Received
    May 8, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT: 1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY; 2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES; 3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR PRESENTATION; AND 4) REDUCES THE NUMBER OF OVERSIZED MALIGNANT CALCIFICATION CLUSTERS MISSED BY EARLIER ALGORITHMS.

    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