PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM is an FDA 510(k)-cleared medical device (K041577) manufactured by Adac Laboratories. 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 24, 2004. Regulation: 8.