510(k) K232870

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) by Varian Medical Systems, Inc. — Product Code IYE

K232870 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)". The FDA issued a decision of Substantially Equivalent on December 21, 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.