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Ge Medical Systems Navigation and Visualization IN
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INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 is an FDA 510(k)-cleared medical device (K040050) manufactured by Ge Medical Systems Navigation and Visualization IN. 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 23, 2004. Regulation: 8.