SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16

SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 is an FDA 510(k)-cleared medical device (K133424) 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 January 16, 2014. Regulation: 8.