Radiance 330 Proton Beam Therapy System

Radiance 330 Proton Beam Therapy System is an FDA 510(k)-cleared medical device (K191521) manufactured by Protom International Holding Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2019. Regulation: 8.