MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) is an FDA 510(k)-cleared medical device (K010548) manufactured by Radionics, A Division of Tyco Healthcare Group LP. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2001. Regulation: 8.