510(k) K250064

Dose+ (1.0) by Mvision AI OY — Product Code MUJ

K250064 is an FDA 510(k) premarket notification submitted by Mvision AI OY for the device "Dose+ (1.0)". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Mvision AI OY has at least 2 other 510(k) clearances on record.