MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A

MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A is an FDA 510(k)-cleared medical device (K133435) 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 December 11, 2013. Regulation: 8.