TRUE BEAM, TRUE BEAM STX, EDGE

TRUE BEAM, TRUE BEAM STX, EDGE is an FDA 510(k)-cleared medical device (K140528) 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 September 4, 2014. Regulation: 8.