SYNGOCIRCULATION DYNAMICPET, VERSION 1.0

SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 is an FDA 510(k)-cleared medical device (K083327) manufactured by Siemens Medical Solutions USA, 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 May 17, 2009. Regulation: 8.