510(k) K240398 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Feb 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3
Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3
Product Description: Rad Open, Classified |
MUJ | None listed |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 2023B, Software Version: 14.0.0.3338.
2. RayStation 2024A, Software Version: 15.0.0.430.
3. RayStation 2024A SP3, Software Version Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.