PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM is an FDA 510(k)-cleared medical device (K130992) 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 June 13, 2013. Regulation: 8.