OEC 9900 ELITE

OEC 9900 ELITE is an FDA 510(k)-cleared medical device (K122234) manufactured by Ge Healthcare Surgery GE Oec 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 August 15, 2012. Regulation: 8.