BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S033 · Decision Jul 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P990066
    Supplement Number
    S033
    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
    July 10, 2009
    Date Received
    May 21, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS. THE COMPONENTS THAT ARE PROPOSED FOR REMOVAL FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.

    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