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510(k) Data Aggregation

    K Number
    K201177
    Device Name
    RadGil2
    Manufacturer
    R3 X-Ray L.L.C
    Date Cleared
    2020-08-17

    (108 days)

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

    R3 X-Ray L.L.C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)
    Device Description
    The RADGIL 2 US x-ray blood irradiator is for use in Hospitals, Medical Centers and blood banks. The RADGIL 2 US x-ray blood irradiator consists of one lead-shielded cabinet containing one monoblock with one X-ray tube inside, one irradiation chamber, one control electronics, one computer for data management and one operator controls panel for the X-ray settings. The RADGIL 2 US x-ray blood irradiator is designed to accommodate a rotating canister of approximately 2.5 litres, to accommodate up to six standard 300 mL blood bags provided the bags are not frozen and the blood bag tubing is not an obstruction. The RADGIL 2 US x-ray blood irradiator is capable of irradiating the blood products to a central dose of 30 Gy, granting a minimum dose >15 Gy and a maximum dose < 50 Gy as required by US clinics, hospitals and blood banks. The RADGIL 2 US has a lockable panel to ensure that only authorized personnel make adjustments.
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