BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P010025 · Decision Mar 15, 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
    LORAD DIGITAL BREAST IMAGER
    PMA Number
    P010025
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    March 15, 2002
    Date Received
    April 30, 2001
    Expedited Review
    N
    Docket Number
    02M-0173

    Advisory Committee Statement

    APPROVAL FOR THE LORAD DIGITAL BREAST IMAGER. THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM MAMMOGRAPHIC SYSTEMS.

    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