syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology is an FDA 510(k)-cleared medical device (K163294) 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 February 5, 2017. Regulation: 8.