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510(k) Data Aggregation

    K Number
    K190894
    Device Name
    TOTIM Patient Cushion Immobilization System
    Manufacturer
    Date Cleared
    2019-04-30

    (25 days)

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

    Essebi Medical SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body, head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition, including Computed Tomography (CT), Magnetic Resonance (MR) Imaging, to support treatment planning.
    Device Description
    TOTIM is a fully sealed, polyurethane foam cushion covered with microfiber polyester tissue for patient positioning and immobilization during simulation, planning and radiation treatment. The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports.
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