TrueBeam, TrueBeam STx, Edge, VitalBeam

TrueBeam, TrueBeam STx, Edge, VitalBeam is an FDA 510(k)-cleared medical device (K213977) 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 June 2, 2022. Regulation: 8.