510(k) K203681

RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review by Brainlab AG — Product Code MUJ

K203681 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review". The FDA issued a decision of Substantially Equivalent on Apr 9, 2021. 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.