BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S015 · Decision Nov 21, 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
    PMA Number
    P990066
    Supplement Number
    S015
    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
    November 21, 2002
    Date Received
    October 3, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE APPROVED SYSTEM TO PERMIT USE OF AN OPTIONAL CONTRAST ENHANCEMENT ALGORITHM (DYNAMIC RANGE MANAGEMENT) INTRODUCTION OF NEW DISPLAY PROTOCOLS AND MINOR CHANGES IN THE DISPLAY SCENARIOS, AND ADDITION OF KEYBOARD SHORTCUTS FOR WINDOW WIDTH/WINDOW LEVEL SETTINGS. THE SUPPLEMENT ALSO INCLUDES CHANGES IN THE LABELING TO REFLECT THE MODIFICATIONS LISTED ABOVE.

    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