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510(k) Data Aggregation

    K Number
    K182395
    Device Name
    OARtrac System
    Manufacturer
    RadialDyne, LLC
    Date Cleared
    2019-03-22

    (199 days)

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

    RadialDyne, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.
    Device Description
    The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is intended for use in photon and electron radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal wall. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to the patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.
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