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510(k) Data Aggregation

    K Number
    K081066
    Device Name
    BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
    Manufacturer
    MEDI-PHYSICS, INC., DBA GE HEALTHCARE
    Date Cleared
    2008-05-05

    (20 days)

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

    MEDI-PHYSICS, INC., DBA GE HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated. The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants. The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.
    Device Description
    The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.
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