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510(k) Data Aggregation

    K Number
    K080888
    Device Name
    MODEIFICATION TO IPLAN RT DOSE
    Manufacturer
    BRAINLAB AG
    Date Cleared
    2008-06-11

    (72 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K994413,K053584
    Why did this record match?
    Reference Devices :

    K994413, K053584

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

    iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the iPlan RT Dose system. It describes the device, its intended use, and its predicate devices, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based only on the provided input. The document is an FDA approval letter and summary, not a study report.

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