510(k) K231052

ExacTrac Dynamic 1.1.2 by Brainlab AG — Product Code IYE

K231052 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "ExacTrac Dynamic 1.1.2". The FDA issued a decision of Substantially Equivalent on May 11, 2023. 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.