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510(k) Data Aggregation

    K Number
    K231852
    Device Name
    BinkieRT
    Manufacturer
    Date Cleared
    2023-11-15

    (145 days)

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

    Papricalab

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BinkieRT is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician. BinkieRT is meant for use with 6 MV photon beams only.
    Device Description
    It is a patient-specific medical device that is mounted in the oral cavity of the patient to fix the temporomandibular joint in the treatment of head and neck radiation, and the planned dose is accurately delivered to the target area, and the tongue is moved in one direction to be spaced apart to minimize the exposure of normal tissue to the surrounding area. The device consists of a Jaw Positioner (Impression, Maxiila, Mandibula), a Tongue Positioner (Head, Paddle), and a Column (Rotation Guide).
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