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Radionics, Inc.
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MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) is an FDA 510(k)-cleared medical device (K001431) manufactured by Radionics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2000. Regulation: 8.