510(k) K252002

Monaco RTP System (6.3) by Elekta Solutions AB — Product Code MUJ

K252002 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Monaco RTP System (6.3)". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Elekta Solutions AB has at least 10 other 510(k) clearances on record.