RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K860606) manufactured by Bionix Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 1986. Regulation: 8.