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

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P050014 · Decision Jul 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
    PMA Number
    P050014
    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
    July 10, 2006
    Date Received
    March 30, 2005
    Expedited Review
    N
    Docket Number
    06M-0295

    Advisory Committee Statement

    APPROVAL FOR THE FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS). THE FCRMS IS A SOFTWARE DEVICE THAT, IN CONJUNCTION WITH A SPECIFIED FUJI COMPUTED RADIOGRAPHY SYSTEM, FORMS THE FUJI COMPUTED RADIOGRAPHY FOR MAMMOGRAPHY (FCRM) DEVICE. FCRM WITH A DEDICATED 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 (SFM) 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