BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P010025 · Supplement: S009 · Decision Jan 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P010025
    Supplement Number
    S009
    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
    January 17, 2007
    Date Received
    November 24, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.

    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