510(k) K250963

PlanOne 1 by Cosylab Jsc, Control System Laboratory — Product Code MUJ

K250963 is an FDA 510(k) premarket notification submitted by Cosylab Jsc, Control System Laboratory for the device "PlanOne 1". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050.