510(k) K202412

ClearRT Helical kVCT for the Radixact Treatment Delivery System by Accuray Incorporated — Product Code IYE

K202412 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "ClearRT Helical kVCT for the Radixact Treatment Delivery System". The FDA issued a decision of Substantially Equivalent on December 18, 2020. 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.