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Ge Medical Systems, Inc.
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INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) is an FDA 510(k)-cleared medical device (K024200) 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 January 15, 2003. Regulation: 8.