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

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P080018 · Decision Nov 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
    PMA Number
    P080018
    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
    November 3, 2010
    Date Received
    July 28, 2008
    Expedited Review
    N
    Docket Number
    10M-0591

    Advisory Committee Statement

    APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. THE DEVICE IS INDICATED FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH, WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, 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 BASED MAMMOGRAPHIC SYSTEMS. THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARDCOPY FILM OR SOFTCOPY DISPLAY AT A WORKSTATION.

    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