TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) is an FDA 510(k)-cleared medical device (K232870) 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 December 20, 2023. Regulation: 8.