510(k) K252977

Halcyon, Ethos Radiotherapy System (5.0) by Varian Medical Systems, Inc. — Product Code IYE

K252977 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Halcyon, Ethos Radiotherapy System (5.0)". The FDA issued a decision of Substantially Equivalent on January 21, 2026. 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.