ProBeam 360 Proton Therapy System v3.0

ProBeam 360 Proton Therapy System v3.0 is an FDA 510(k)-cleared medical device (K252815) 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 April 22, 2026. Regulation: 8.