510(k) K192377

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

K192377 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon". The FDA issued a decision of Substantially Equivalent on Feb 10, 2020. 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 205 other 510(k) clearances on record.