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510(k) Data Aggregation

    K Number
    K013279
    Date Cleared
    2001-10-18

    (16 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MOSFET AUTOSENSE, MODEL TN-RD-60

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "TN-RD-60 Patient Dose Verification System" (later referred to as "MOSFET AutoSense Patient Dose Verification System"). This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    The document does not contain specific acceptance criteria or details of a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided here. The clearance letter only confirms that the FDA has reviewed the submission and made a substantial equivalence determination based on the provided information.

    Therefore, I cannot provide the requested information from the text.

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