HISPEED NX/I CT SCANNER SYSTEM

HISPEED NX/I CT SCANNER SYSTEM is an FDA 510(k)-cleared medical device (K991716) manufactured by Ge 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 June 17, 1999. Regulation: 8.