Biograph mMR with syngo MR E11P-AP01 system software

Biograph mMR with syngo MR E11P-AP01 system software is an FDA 510(k)-cleared medical device (K200213) 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 May 10, 2020. Regulation: 8.