GE SIGNA EXCITE MR SURGICAL OPTION

GE SIGNA EXCITE MR SURGICAL OPTION is an FDA 510(k)-cleared medical device (K043262) manufactured by GE Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2005. Regulation: 8.