syngo.CT Coronary Analysis; syngo.CT Vascular Analysis

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is an FDA 510(k)-cleared medical device (K173637) 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 March 29, 2018. Regulation: 8.