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510(k) Data Aggregation

    K Number
    K093967
    Device Name
    VARIAN TREATMENT
    Date Cleared
    2010-07-12

    (201 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

    Device Description

    Varian Treatment is a software device that performs an interface role to the Siemens, GE, and Elekta linear accelerator systems. Varian Treatment (VT) allows treatment plans and reference images to be retrieved from the Varian System Database. VT sends the selected field of the loaded treatment plan down to the machine's treatment control software (TCS). VT verifies the field's planned parameters against the actual parameters of the TCS delivery system for accuracy before beam authorization is granted; this process is repeated for each field selected by the user. VT creates and transfers treatment records to the Varian System Database for storage.

    AI/ML Overview

    The provided text is a 510(k) summary for the Varian Treatment device. This document primarily describes the device's function, indication for use, and regulatory classification. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested information based on the given input. The document is a regulatory filing, not a scientific study report.

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