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510(k) Data Aggregation

    K Number
    K062135
    Device Name
    ART SHIELDED BREAST APPLICATOR
    Date Cleared
    2006-11-07

    (104 days)

    Product Code
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED RADIATION THERAPY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.
    Device Description
    The Advanced Radiation Therapy (ART) Shielded Breast Applicator is used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned either external to a mammography style paddle which immobilizes the breast or directly against the breast with intact skin. Once the target has been immobilized and imaged the applicator is placed such that it is aligned with the target. The exterior shielding of the applicator will reduce dose to the surrounding tissue. The applicator is available in 5 sizes - 4, 5, 6, 7 and 8 cm ID.
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    K Number
    K060299
    Device Name
    ART BRACHYTHERAPY APPLICATOR
    Date Cleared
    2006-06-06

    (120 days)

    Product Code
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED RADIATION THERAPY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source near the breast to deliver radiation dose to the underlying tissue in areas of intact skin.
    Device Description
    The Advanced Radiation Therapy (ART) Breast Brachytherapy Applicator is a rigid applicator used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned external to the breast to receive the HDR afterloader source via catheter lumens. The position and placement of the applicator is verified by means of radiographic images and the travel distance of the HDR source in the lumens is determined radiographically by using the check cable of the afterloader equipment. With the applicator properly immobilized on the breast surface, the HDR treatment process can begin according to established protocols.
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