510(k) K182687

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System by Accuray Incorporated — Product Code IYE

K182687 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System". The FDA issued a decision of Substantially Equivalent on November 23, 2018. 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.