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Imris, Inc.
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1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) is an FDA 510(k)-cleared medical device (K103506) 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 February 1, 2011. Regulation: 8.