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510(k) Data Aggregation

    K Number
    K060737
    Device Name
    SINMED POSITIONING DEVICES
    Manufacturer
    SINMED BV
    Date Cleared
    2006-03-31

    (11 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINMED BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. Fixation and (re)positioning of the patient during radiotherapy and diagnostics.
    Device Description
    The submission describes several types of immobilization systems and cushions for radiotherapy and diagnostics: - Head and shoulder positioning and immobilization systems (Baseplates): Posifix 1,2,4,5,7 head and neck systems, Positilt head inclination system, Posifix Pediatric, Headsupports, Blocks and wedges, Shouldersupport cushion. These are designed to position and reposition the head and neck. - Head and shoulders immobilization systems (Extensionplates): Posifix-EXT systems, Shoulderretractor, Couchtop Cover. These are intended to position the head and neck outside the couch. - Lung and thorax immobilization systems: Thorawedge, Posirest, Posiboard, PET-armsupport. These are for positioning the patient for irradiation in the lung and thorax area. - Pelvis and lower extremities immobilization systems (Bellyboard system): Bellyboard, Prone thorax support cushion for Bellyboard. These are developed to reduce irradiated small bowel volume in gynaecological patients. - Pelvis and lower extremities immobilization systems: Posifix-12, Multifix, Combifix-system (Baseplate with Kneefix and Feetfix), Multi Purpose Support cushions. These are for positioning of hip and lower extremities. - Repovac Cushions: Vacuum cushions filled with polystyrene beads that can be made vacuum to follow and keep the contour of a patient for reproducible positioning. - Posicast immobilization systems: Thermoplastic mask material for patient immobilization.
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