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510(k) Data Aggregation

    K Number
    K223465
    Device Name
    RadianceTx Radionuclide Brachytherapy Source
    Manufacturer
    Radiance Therapeutics Inc.
    Date Cleared
    2023-01-11

    (55 days)

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

    Radiance Therapeutics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of umors and benign growths. The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.
    Device Description
    Not Found
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