GE DIASONICS GATEWAY AND GATEWAY FX

GE DIASONICS GATEWAY AND GATEWAY FX is an FDA 510(k)-cleared medical device (K993069) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 1999. Regulation: 8.