TrueBeam, TrueBeam STX, Edge and VitalBeam

TrueBeam, TrueBeam STX, Edge and VitalBeam is an FDA 510(k)-cleared medical device (K252948) 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 October 6, 2025. Regulation: 8.