syngo.via MI Workflows; Scenium; syngo MBF

syngo.via MI Workflows; Scenium; syngo MBF is an FDA 510(k)-cleared medical device (K232000) 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 November 27, 2023. Regulation: 8.