MAGNETOM Avantofit, MAGNETOM Skyrafit

MAGNETOM Avantofit, MAGNETOM Skyrafit is an FDA 510(k)-cleared medical device (K162102) manufactured by Siemens Medi Cal Solutions, 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 November 21, 2016. Regulation: 8.