MRGP OPTICAL TRACKING UNIT

MRGP OPTICAL TRACKING UNIT is an FDA 510(k)-cleared medical device (K991943) manufactured by Philips Medical Systems (Cleveland), Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 1999. Regulation: 8.