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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)

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.

To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent Graft Versus Host Disease.

The Raycell Mk1 x-ray blood irradiator consists of one cabinet containing one x-ray tube, one highvoltage power supply, one radiation shielding chamber, control electronics, an internal cooling system, two removable shielding access panels to the irradiation chamber, a touch-based Graphical User Interface, and additional operator controls. The operator places the blood products to be irradiated in the canister or syringe holder, opens the door, places the canister or syringe holder on the turntable, closes the door and indicates the irradiation cvcle on the Graphical User Interface. The Operator then uses the Operator controls to start the irradiation cycle. The design of this device is substantially equivalent to the predicate device.

The SANGRAY is an x-ray irradiation system intended for use in the irradiation of blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft versus host disease (GVHD).

The X-ray irradiation system SANGRAY consists of a power supply (high-voltage generation unit), controller panel (console), and a shielded protection unit which contains two vertically opposed X-ray tube assemblies that generate X-ray beams. Blood products are placed into a tray and irradiated with the X-rays in a sample chamber. The system has a built-in dosimeter which measures the exposure dose in real time and ensures that the X-ray irradiation is stopped automatically when the preset dose is reached. If the power supply fails during the X-ray irradiation, the dosimeter keeps the integral dose value in memory, which allows the operator to continue the X-ray irradiation after power is recovered.

The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines. The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.

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.

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.

The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease (GVHD) in accordance with applicable FDA, AABB, Health Canada, and European guidelines. The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operative (between three) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

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To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.

The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the gammacell, closing the safety door and pressing the 'start' button. Upon start of the cycle, the unit moved the beaker to the irradiation position. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to the unload position and the audible alarm sounds.

The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used 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).

The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer.

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.

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.

The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.

The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models. The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.