SOMATOM Definition AS Open (VA48)

SOMATOM Definition AS Open (VA48) is an FDA 510(k)-cleared medical device (K143409) 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 March 25, 2015. Regulation: 8.