BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S012 · Decision Apr 3, 2002
    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 MAMOGRAPHY SYSTEM
    PMA Number
    P990066
    Supplement Number
    S012
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 3, 2002
    Date Received
    March 12, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A SUPPLIER OF THE HIGH VOLTAGE (HV) TANK ELECTRONIC BOARDS. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.

    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