510(k) K212420

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio by Brainlab AG — Product Code LLZ

K212420 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio". The FDA issued a decision of Substantially Equivalent on Dec 16, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Brainlab AG has 141 other 510(k) clearances on record.