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    K Number
    K082921
    Device Name
    RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
    Manufacturer
    RAD SOURCE TECHNOLOGIES, INC.
    Date Cleared
    2009-02-17

    (139 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAD SOURCE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
    Device Description
    The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.
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