INNOVA 4100, INNOVA 3100

INNOVA 4100, INNOVA 3100 is an FDA 510(k)-cleared medical device (K042053) 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 August 25, 2004. Regulation: 8.