syngo.MR Neurology, syngo.MR Oncology

syngo.MR Neurology, syngo.MR Oncology is an FDA 510(k)-cleared medical device (K151353) 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 August 6, 2015. Regulation: 8.