510(k) K171086

Accuray Precision Treatment Planning System by Accuray Incorporated — Product Code IYE

K171086 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "Accuray Precision Treatment Planning System". The FDA issued a decision of Substantially Equivalent on June 8, 2017. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Accuray Incorporated has at least 10 other 510(k) clearances on record.