510(k) K212794

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

K212794 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 September 30, 2021. 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.