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510(k) Data Aggregation
K Number
K190894Device Name
TOTIM Patient Cushion Immobilization System
Manufacturer
Date Cleared
2019-04-30
(25 days)
Product Code
Regulation Number
892.5050Why 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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