syngo.via MI WorkFlows, Scenium, syngo MBF

syngo.via MI WorkFlows, Scenium, syngo MBF is an FDA 510(k)-cleared medical device (K211459) 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 June 9, 2021. Regulation: 8.