BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P010025 · Supplement: S017 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P010025
    Supplement Number
    S017
    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 23, 2009
    Date Received
    November 5, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SELENIA DIMENSION 2D FFDM TO BE USED IN A MOBILEENVIRONMENT WITH THE FOLLOWING DESIGN CHANGES:1) ACQUISITION STATION:A) THE ACQUISITION STATION MONITOR WILL BE MOUNTED ON A FIXED MOUNT MECHANISM THAT ALLOWS POSITIONING OF THE MONITOR VIA A SPRING LOADED LOCKING DEVICE. THE MOBILE SYSTEM MONITOR CAN BE FIXED MOUNTED ON THE LEFT,RIGHT OR CENTER POSITION.B) THE KEYBOARD TRAY HAS BEEN SECURED WITH A SPRING LOADED LATCHING MECHANISM TO PREVENT MOVEMENT DURING TRANSPORT.C) THE BAR CODE SCANNER CAN BE MOUNTED EITHER ON THE LEFT OR RIGHT SIDE OF THE MONITOR AS NEEDED IN THE MOBILE APPLICATION.D) THE X-RAY SHIELD IS REPLACED WITH NON ATTENUATING, COSMETIC CLEAR PLASTIC (AS COVER GAP FILLERS). 2) GANTRY:A) THE VERTICAL TRAVEL ASSEMBLY (VTA) HAS BEEN CONFIGURED WITH AN ELECTROMAGNETICBRAKE TO PREVENT UNWANTED TRAVEL DURING TRANSPORT. B) A MOUNTING FEATURE HAS BEEN ADDED TO THE TOP SECTION OF THE GANTRY FRAME FORSUPPLEMENTAL SUPPORT IN A COACH/VAN.C) THE UPPER MOVEMENT LIMIT OF THE C-ARM IS NOW CONFIGURABLE FROM 6' 10" TO 7' 10" TO ALLOW FOR LOWER CEILINGS IN A COACH/VAN.3) INSTRUCTIONS FOR USE AND QC MANUAL:A MOBILE ADDENDUM INCLUDES CURRENT USER MANUAL WITH ADDED WARNINGS AND INSTRUCTIONSREGARDING MOBILE USE. IN ADDITION, THE MOBILE ADDENDUM INCLUDES INSTRUCTIONS TO THE USER ON THE QC TESTS THAT ARE REQUIRED TO BE PERFORMED PRIOR TO CLINICAL USE AFTER MOVEMENT.

    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