MAGNETOM Sempra with syngo MR E11S

MAGNETOM Sempra with syngo MR E11S is an FDA 510(k)-cleared medical device (K163211) 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 January 26, 2017. Regulation: 8.