BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P030010 · Supplement: S001 · Decision Jul 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
    PMA Number
    P030010
    Supplement Number
    S001
    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 7, 2005
    Date Received
    January 19, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CHANGE THE ACQUISITION WORKSTATION (AWS) FROM THE CURRENTLY APPROVED UNIX-BASED SUN WORKSTATION WITH SOLARIS 8 OPERATING SYSTEM TO A FUJITSU/SIEMENS M420PC WITH SYNGO OPERATING SYSTEM AND THE PROPOSED CHANGES ALLOWING THE SOFTWARE DRIVERS FOR THE DETECTOR INTERFACE (DRUL) TO BE WINDOWS XP BASED.

    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