CENTRION 500 C-ARM SYSTEM

CENTRION 500 C-ARM SYSTEM is an FDA 510(k)-cleared medical device (K050866) manufactured by Osteosys Co.,Ltd. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2005. Regulation: 8.