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The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The Sumitomo Proton Therapy System (PTS) is a large-scale medical electrical system that consists of an integrated system of medical electrical equipment and non-medical electrical components to provide proton beam radiation therapy. The Sumitomo PTS consists of a 230 MeV Cyclotron, an Energy Selection System, a Beam Transport System, and a Gantry Treatment System. The new Sumitomo PTS is a modification of the Sumitomo PTS cleared for marketing under K130426 in November 2013. The purpose of the current 510(k) premarket notification is to add the pencil beam scanning functionality to the cleared Sumitomo PTS. The pencil beam scanning function allows for precise treatment of complex cancers, such as tumors located near critical structures and tumors with special shapes, including multi-site targets, without the need for beam shaping devices such as collimators or compensators. The pencil beam scanning function also produces a radiation field directly from the beam scan path layer by layer, which shortens the treatment duration.

The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The Sumitomo Proton Therapy System (PTS) is a large-scale medical electrical system that consists of an integrated system of medical electrical equipment and nonmedical electrical components to provide proton beam radiation therapy. The Sumitomo PTS consists of a 230 MeV Cyclotron, an Energy Selection System, a Beam Transport System, and a Gantry Treatment System.