BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S016 · Decision Feb 19, 2004
    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 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P990066
    Supplement Number
    S016
    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
    February 19, 2004
    Date Received
    September 2, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN ERGONOMICS, THE IMAGE ACQUISITION CHAIN, IMAGE PRESENTATION ON THE AWS, AND CONNECTIVITY. IN ADDITION THE APPLICATION REQUESTED ADDITIONAL IMAGE QUALITY CLAIMS AND QC MANUAL CHANGES FOR QC TEST TECHNIQUE FACTORS AND PROCEDURES UNDER MQSA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.

    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