INNOVA AND INNOVA 2000 S

INNOVA AND INNOVA 2000 S is an FDA 510(k)-cleared medical device (K022322) manufactured by Ge Medical Systems, 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 October 7, 2002. Regulation: 8.