510(k) K190664

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review by Brainlab AG — Product Code MUJ

K190664 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review". The FDA issued a decision of Substantially Equivalent on Apr 12, 2019. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Brainlab AG has 141 other 510(k) clearances on record.