OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS

OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS is an FDA 510(k)-cleared medical device (K983669) 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 November 17, 1998. Regulation: 8.