MEVION S250i Proton Beam Radiation Therapy Device

MEVION S250i Proton Beam Radiation Therapy Device is an FDA 510(k)-cleared medical device (K172848) manufactured by Mevion Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2017. Regulation: 8.