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The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot® System provides accurate, precise. and continuous localization of a treatment isocenter by using RayPilot@ HypoCath®, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification. The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.

The RayPilot system is designed to provide accurate, objective and continuous localization of a treatment target for patient setup before treatment and target position monitoring during radiation therapy. The RayPilot system is an electromagnetic positioning system, which detects the transmitter in the RayPilot HypoCath, placed in the prostate. The RayPilot HypoCath is removed after finalized treatment. The RayPilot system provides objective information about the location of the treatment target in real-time in 3 dimensions. The system operator uses the information to setup the patient for treatment and to monitor the position during radiation delivery.