syngo.via MI Workflows VB40A, Scenium

syngo.via MI Workflows VB40A, Scenium is an FDA 510(k)-cleared medical device (K191309) manufactured by Siemens Medical Soultions 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 July 18, 2019. Regulation: 8.