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510(k) Data Aggregation

    K Number
    K993552
    Device Name
    ISOSEED PD-103
    Date Cleared
    2000-03-31

    (163 days)

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

    BEBIG ISOTOPENTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor. The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
    Device Description
    The BEBIG IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold wire. Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 are provided non-sterile and must be sterilized prior to use.
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