BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P080018 · Supplement: S001 · Decision Dec 1, 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 CR MAMMOGRAPHY FEATURE
    PMA Number
    P080018
    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
    December 1, 2010
    Date Received
    November 3, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. 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 HARD COPY FILM OR SOFT COPY 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