510(k) K232113

Halcyon, Ethos Radiotherapy System by Varian Medical Systems, Inc. — Product Code IYE

K232113 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Halcyon, Ethos Radiotherapy System". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.