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510(k) Data Aggregation

    K Number
    K141038
    Device Name
    ANT MODEL 1
    Date Cleared
    2014-11-12

    (204 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NUCLIDE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. ANT Model 1 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
    Device Description
    ANT Model 1 is a singly-encapsulated Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive material. There are two versions of the ANT Model 1. The ANT Model 1 Type-Y contains a solid 169Ytterbium pellet. The ANT Model 1 Type-I contains a solid nonradioactive Ytterbium pellet onto which is plated radioactive 125Iodine. In both cases, the capsule which contains the pellet consists of a deep-drawn titanium can which is closed on the end with a titanium plug which is laser-welded to the can. The ANT Model 1 Brachytherapy Source emits gamma rays and characteristic x-rays from the decay of the respective radionuclides.
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