ProBeam 360° Proton Therapy System

ProBeam 360° Proton Therapy System is an FDA 510(k)-cleared medical device (K221791) manufactured by Varian Medical Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 2022. Regulation: 8.