
Ge Medical Systems, LLC
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LIGHTSPEED 7.0 CT SCANNER SYSTEM is an FDA 510(k)-cleared medical device (K040372) manufactured by Ge Medical Systems, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2004. Regulation: 8.