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Imris, Inc.
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NEURO II-SE, MODELS OR-MB-DR AND OR-DR is an FDA 510(k)-cleared medical device (K061916) manufactured by Imris, 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 10, 2006. Regulation: 8.