510(k) K161136

Precision Treatment Planning System by Accuray Incorporated — Product Code MUJ

K161136 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "Precision Treatment Planning System". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Accuray Incorporated has at least 10 other 510(k) clearances on record.