LIGTHSPEED 3.0 CT SCANNER SYSTEM

LIGTHSPEED 3.0 CT SCANNER SYSTEM is an FDA 510(k)-cleared medical device (K002978) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2000. Regulation: 8.