SYNGO DUAL ENERGY SOFTWARE PACKAGE

SYNGO DUAL ENERGY SOFTWARE PACKAGE is an FDA 510(k)-cleared medical device (K132902) 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 April 6, 2014. Regulation: 8.