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510(k) Data Aggregation

    K Number
    K090321
    Device Name
    RIC CONFORMAL SOURCE, MODEL 100
    Manufacturer
    RI CONSULTANTS, LLC
    Date Cleared
    2009-05-27

    (107 days)

    Product Code
    ONL, KXK
    Regulation Number
    892.5730
    Why did this record match?
    Product Code :

    ONL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity up to 200 mCi is indicated for treatment on the surface of tumors. It can be used either as primary surface application to treat intact tumors or as treatment after excision of primary or recurrent tumors. It can be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other treatable tumors could be commonly treated by the RIC Conformal Source, containing 32Phosphorus.
    Device Description
    RIC Conformal Source Model 100 Brachytherapy Source is designed for use in medical Brachytherapy applications. The capacity of each source is up to 200 millicuries of 32Phosphorus. The physician could prescribe a physical size up to 50mm by 100mm. This RIC Conformal Source is a flat flexible planar radioactive 32Phosphorus polymeric film that could be made conformal to different surface geometries such as flat, concave or convex semi-cvlindrical shapes through the use of an appropriately shaped shield / holder or by placement on an area to be treated and made conformal by the weight of a flexible compliant media. At the option of the prescribing physician, the RIC Conformal Source could be attached to a manual radionuclide applicator (available from RI Consultants, Class I device, 892.5650) to facilitate handling and to provide shielding to the clinician. The RIC Conformal Source consists of 32Phosphorus chemically bound to the biocompatible polymeric film. The polymeric film thickness is 0.3mm (0.012 inch) to 0.7 mm (0.028 inch). The 32Phosphorus polymeric film is then coated with a flexible biocompatible silicone coating which is about 0.01 mm (0.0005 inch) thick. The 32Phosphorus is chemically bonded to the polymer molecule and is an integral part of the film.
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