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The PROBEAT-CR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The PROBEAT-CR is a proton beam irradiation system. which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose. dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems: Beam production system (Accelerator system (LINAC. Synchrotron), Beam transport system (Low/High Energy Beam Transport systems)), Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam. (Gantry Room (Scanning Nozzle, Rotating Gantry, Patient Positioning System, Orthogonal X-ray system, Cone Beam CT), Fixed Beam Room (Patient Positioning System, Orthogonal X-ray system, Treatment Control and Safety System)). The subject PROBEAT-CR is a modification to the cleared PROBEAT-CR to include the incorporation of the previously cleared Real Time Image Gating System for Proton Beam Therapy Systems ("RGS" or "RGPT") (K171049) for tracking implanted fiducials to qate the delivery of the proton beam, and the addition of an optional patient couch top extension as an accessory to allow for different patient positioning configurations.

The PROBEAT-CR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site. The PROBEAT-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems: - Beam production system - Accelerator system (LINAC, Synchrotron). - Beam transport system (Low/High Energy Beam Transport systems). - Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam. - Gantry Room - Scanning Nozzle - Rotating Gantry - Patient Positioning System - Orthogonal X-ray system - Cone Beam CT - Fixed Beam Room - Patient Positioning System . - Orthogonal X-ray system . - Treatment Control and Safety System

The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment. The beam delivery system is composed of the following components - Gantry Room o - . Rotating Gantry - Scanning Nozzle . - . Patient Positioning System - Cone Beam CT / X-ray Imaging System . - Fixed Beam Room o - . Scanning Nozzle - Patient Positioning System 트 - . Cone Beam CT / X-ray Imaging System The beam production system is composed of the following components - Accelerator system (LINAC, Synchrotron) o - O Beam transport system (Low/High Energy Beam Transport systems) The system incorporates several optional features and accessories, namely: - The Mini Ridge Filter ("mRF") is an optional accessory to modify the beam of the o PROBEAT-V system. The mRF is installed manually and may be used in conjunction with the range shifters inside the nozzle or extended range shifter. The mRF can be added to the cleared PROBEAT-V nozzle to spread out the Bragg peak along the axis of the beam in order to reduce the amount of beam energy in the delivery of proton radiation to defined target volumes. - Beam gating function allowing for interface with cleared external gating systems to o control the beam delivery for treatment such as to synchronize irradiation with respiration. Although the overall treatment time tends to be longer than the treatment time without gating, the extension of the treatment time will not affect irradiation performance to the target treatment site. Instead, the gating functionality may limit radiation exposure to regions outside of the target treatment volume. - Allows for use of fluoroscopy during proton irradiation at the physician's discretion. o Fluoroscopy may be used for observation of treatment site during treatment, which could be used for interruption of the treatment or analysis for treatment planning.

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.