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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 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.

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

The GammaBeam 500 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system that is designed to be a dedicated, standalone device for performing total body irradiation (TBI). The device consists of a source head, main frame, base, and controls. The design of this device is substantially equivalent to the predicate device Theratron Phoenix. The GammaBeam 500 is aimed to deliver total body irradiation to patients by generating a large fixed radiation treatment field at an extended Source - to - Skin Distance (SSD). This is a common radiotherapy technique performed by many clinics worldwide. A dedicated device improves the safety, effectiveness and clinical workflow of these treatments. The unit will be operated in a similar manner as the predicate and has the same redundant mechanisms for safety, auxiliary source drawer lock, secondary and manual source return, emergency stop switches on the unit and control console, source position indicator, and operational and inhibit state interlocks.

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

The GammaBeam 100 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system. The device consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is substantially equivalent to predicate device Theratron Phoenix.