510(k) K170816

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM by Brainlab AG — Product Code LLZ

K170816 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM". The FDA issued a decision of Substantially Equivalent on Sep 26, 2017. 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.