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510(k) Data Aggregation

    K Number
    K092871
    Device Name
    TRILOGY MX
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2009-11-30

    (73 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K050442,K072916,K042720,K063270,K081036,K003636,K071992
    Predicate For
    K102915,K111106,K111862
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    Device Description

    The Trilogy Mx™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

    AI/ML Overview

    The provided document is a 510(k) summary for the Trilogy Mx Radiotherapy Treatment System. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The document primarily focuses on the device's intended use, classification, and substantial equivalence to predicate devices, which is standard for a 510(k) submission.

    Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from the provided text.

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