MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software is an FDA 510(k)-cleared medical device (K163312) 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.