BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P050014 · Supplement: S002 · Decision Aug 11, 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
    FULL FIELD DIGITAL MAMMOGRAPHY
    PMA Number
    P050014
    Supplement Number
    S002
    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
    August 11, 2009
    Date Received
    July 15, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.

    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