Devices · RaySearch Laboratories AB (PUBL)

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

510(k)K240398RadiologyMUJ

RaySearch Laboratories AB (PUBL) is listed for RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (K240398). The FDA list gives April 4, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MUJ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240398

Official FDA database record

Date of final decision: April 4, 2025
Company on the FDA list: RaySearch Laboratories AB (PUBL)
Lead panel: Radiology
Primary product code: MUJ
openFDA device name for the code: System, Planning, Radiation Therapy Treatment
Device class: 2
Regulation number: 892.5050
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary