GE LIGHTSPEED ACT FP16

GE LIGHTSPEED ACT FP16 is an FDA 510(k)-cleared medical device (K091673) 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 23, 2009. Regulation: 8.