TrueBeam-TrueBeam STx-Edge

TrueBeam-TrueBeam STx-Edge is an FDA 510(k)-cleared medical device (K162472) 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 January 18, 2017. Regulation: 8.