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510(k) Data Aggregation

    K Number
    K180515
    Device Name
    GammaTile
    Manufacturer
    Isoray Medical Inc.
    Date Cleared
    2018-07-06

    (129 days)

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

    Isoray Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
    Device Description
    The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The GammaTile™ is designed to provide "adjuvant" radiation therapy therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of recurrent brain neoplasms. GammaTile™ is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
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