LIGHTSPEED 4.0 CT SCANNER SYSTEM

LIGHTSPEED 4.0 CT SCANNER SYSTEM is an FDA 510(k)-cleared medical device (K013561) 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 November 7, 2001. Regulation: 8.