MAGNETOM Amira, MAGNETOM Sempra

MAGNETOM Amira, MAGNETOM Sempra is an FDA 510(k)-cleared medical device (K183221) 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 13, 2019. Regulation: 8.