OPTICAL TRACKING SYSTEM (OTS)

OPTICAL TRACKING SYSTEM (OTS) is an FDA 510(k)-cleared medical device (K964801) manufactured by Radionics Software Applications, 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 June 1, 1997. Regulation: 8.