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510(k) Data Aggregation

    K Number
    K252884
    Device Name
    Guided Aarhus Applicator Set
    Manufacturer
    Varian Medical Systems
    Date Cleared
    2025-11-19

    (70 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K222775
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Guided Aarhus Applicator Set is indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus, and endometrium using HDR brachytherapy.

    Device Description

    The Guided Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy.

    Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

    Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

    AI/ML Overview

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