510(k) K170086

Pinnacle Radiation Therapy Planning System by Philips Medical Systems (Cleveland), Inc. — Product Code MUJ

K170086 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "Pinnacle Radiation Therapy Planning System". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), 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.