BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S004 · Decision Dec 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P990066
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    MUE
    Generic Name
    Full field digital, system, x-ray, mammographic
    Regulation Number
    892.1715
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 6, 2001
    Date Received
    June 8, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE IMAGE CHAIN SOFTWARE, SPECIFICALLY THE AUTOMATIC OPERATING PARAMETERS (AOP) AND THE AUTO-CONTRAST AND THICKNESS COMPENSATION ALGORITHMS; THE ADDITION OF SOME NEW FEATURES TO THE ACQUISITION WORK STATION AND THE REVIEW WORK STATION THAT PROVIDE MORE OPTIONS FOR IMAGE DISPLAY AND PRINTING; AND REVISED LABELING TO ADDRESS THE CHANGES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUE Full Field Digital, System, X-Ray, Mammographic