ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY is an FDA 510(k)-cleared medical device (K121448) manufactured by Elekta Inc. D/B/A Nucletron Corporation. 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 1, 2012. Regulation: 8.