MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)

MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) is an FDA 510(k)-cleared medical device (K971684) 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 August 4, 1997. Regulation: 8.