SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY

SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY is an FDA 510(k)-cleared medical device (K073003) manufactured by Siemens Medi Cal Solutions, 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 February 6, 2008. Regulation: 8.