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510(k) Data Aggregation

    K Number
    K974210
    Device Name
    SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
    Manufacturer
    RAD-SOURCE, INC.
    Date Cleared
    1998-03-30

    (140 days)

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

    RAD-SOURCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RS 3000 Shielded Cabinet X-ray Radiation Source is 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 for 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 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller.
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