510(k) K241876

Vitesse (5.0) by Varian Medical Systems — Product Code MUJ

K241876 is an FDA 510(k) premarket notification submitted by Varian Medical Systems for the device "Vitesse (5.0)". The FDA issued a decision of Substantially Equivalent on October 23, 2024. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems has at least 10 other 510(k) clearances on record.