510(k) K240431

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface by Brainlab AG — Product Code IYE

K240431 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface". The FDA issued a decision of Substantially Equivalent on July 24, 2024. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Brainlab AG has at least 10 other 510(k) clearances on record.