510(k) K243142

Cranial 4Pi Immobilization by Brainlab AG — Product Code IYE

K243142 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Cranial 4Pi Immobilization". The FDA issued a decision of Substantially Equivalent on June 23, 2025. 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.