TrueBeam, TrueBeam STx, Edge

TrueBeam, TrueBeam STx, Edge is an FDA 510(k)-cleared medical device (K171733) 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 July 11, 2017. Regulation: 8.