OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII is an FDA 510(k)-cleared medical device (K990326) 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 March 3, 1999. Regulation: 8.