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The X-ray Imaging System is intended to be used as a patient setup and localization tool that is capable of processing orthogonal or CBCT images acquired at the start of the treatment. The images will be compared against Digitally Reconstructed Radiographs or CTs that were used to define the treatment plan. The comparison will generate position correction vectors if required and provide them to the McLaren Proton Treatment System for patient position corrections prior to treatment.

The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System (K160063). The software product described by this document is considered a sub-system of the McLaren Proton Treatment System. The software product integrates with the following components of the McLaren Proton Treatment System: . X-ray generator & tube assembly Amorphous silicon flat-panel detector . Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient's position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and Digitally Reconstructed Radiographs or CTs.