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510(k) Data Aggregation

    K Number
    K040766
    Device Name
    OPTISOURCE, MODEL 1032P
    Manufacturer
    INTERNATIONAL BRACHYTHERAPY S.A.
    Date Cleared
    2004-07-22

    (119 days)

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

    INTERNATIONAL BRACHYTHERAPY S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiSource103 implants are indicated for interstitial implantation of select focalized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    OptiSource103 is a permanent interstitial implant 5.0 mm long by 0.88 mm in diameter with a polymeric shell and containing Pd-103 in two solid polymeric cylinders separated by a gold marker to provide visibility.
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