510(k) K130992

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM by Philips Medical Systems (Cleveland), Inc. — Product Code IYE

K130992 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "PINNACLE3 RADIATION THERAPY PLANNING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.