BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P010017 · Supplement: S007 · Decision Feb 13, 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
    FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P010017
    Supplement Number
    S007
    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
    February 13, 2006
    Date Received
    January 20, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE CHANGES TO CORRECT SEVERAL "BUGS" THAT IMPROVE SERVICE WORKFLOW EFFICIENCY, IMPROVE USER WORKFLOW EFFICIENCY, AND IMPROVE IMAGE ARCHIVING.

    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