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Optoacoustics, Ltd.
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MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE is an FDA 510(k)-cleared medical device (K121239) manufactured by Optoacoustics, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2012. Regulation: 8.