BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P990066 · Supplement: S019 · Decision May 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P990066
    Supplement Number
    S019
    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
    May 25, 2005
    Date Received
    April 18, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN TWO SOFTWARE MODIFICATIONS THAT HAVE BEEN MADE TO THE ACQUISITION WORKSTATION (AWS) AND FOR AN ADDITIONAL SUPPLIER FOR THE CONDITIONER (CHILLER FOR THE IMAGE RECEPTOR). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED AS FOLLOWS: THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEM.

    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