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Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.