510(k) K240398

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 by RaySearch Laboratories AB (PUBL) — Product Code MUJ

K240398 is an FDA 510(k) premarket notification submitted by RaySearch Laboratories AB (PUBL) for the device "RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. RaySearch Laboratories AB (PUBL) has at least 10 other 510(k) clearances on record.