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Igt, LLC Dba Eigen
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MULTI-MODALITY IMAGE FUSION is an FDA 510(k)-cleared medical device (K120187) manufactured by Igt, LLC Dba Eigen. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2012. Regulation: 8.