# K252109: RayStation (2024A SP3)

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Dec 22, 2025 after 168 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K010975 (2001). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3, RaySearch Laboratories AB (PUBL) (2025) Summary page 6.

## Indications for use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

Source page: https://510kreport.com/device/K252109
Methodology: https://510kreport.com/methodology