SIMVIEW(TM) 3000

SIMVIEW(TM) 3000 is an FDA 510(k)-cleared medical device (K946053) 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 30, 1995. Regulation: 8.