OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) is an FDA 510(k)-cleared medical device (K081281) manufactured by 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 May 19, 2008. Regulation: 8.