510(k) K250099

Mobius3D (4.1) by Varian Medical Systems — Product Code IYE

K250099 is an FDA 510(k) premarket notification submitted by Varian Medical Systems for the device "Mobius3D (4.1)". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems has at least 10 other 510(k) clearances on record.