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St Jude Medical
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ENSITE VERISMO SEGMENTATION TOOL V.2.0 is an FDA 510(k)-cleared medical device (K101697) manufactured by St Jude Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2010. Regulation: 8.