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510(k) Data Aggregation

    K Number
    K180697
    Device Name
    Pseudo-Patient
    Manufacturer
    Date Cleared
    2018-07-10

    (116 days)

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

    RTsafe, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.
    Device Description
    The Personalized PseudoPatient™ PV is a precise model of a patient's CT-scan. Bone structure and external contour are 3D printed using bone equivalent material. The PseudoPatient™ is a pre-treatment end-to-end verification device. The device verifies the TPS dose calculations as well as the following parts of the treatment chain: patient immobilization, image guidance, and treatment delivery. The 3D printed, Personalized PseudoPatient™ PV is loaded with one of the following available types of dosimeters: ion chamber (IC) insert (or any kind of insert for point dosimetry), and/or film insert (FL). The insertcan be relocated depending on demands of treatment. The ion chamber inserts are specifically designed for the detector type indicated by the end user and constructed of Poly(methyl methacrylate) (PMMA). The PseudoPatient™ FL is equipped with a Real Water (RW3) insert to accommodate a dosimetry film (filled with water by the end-user).
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