510(k) K254010

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface by Brainlab SE — Product Code IYE

K254010 is an FDA 510(k) premarket notification submitted by Brainlab SE for the device "ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface". The FDA issued a decision of Substantially Equivalent on January 14, 2026. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.