510(k) K220141 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 11B
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Apr 15, 2022 |
| Received | Jan 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220141
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0.
Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1.
Open, Classified |
MUJ | None listed |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 11B, Software Version: 12.0.0.932.
2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221.
3. RayStation 11B Service Pack Open, Classified |
MUJ | None listed |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119
Software Version: RayStation 11B an Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | None listed |
| Apr 5, 2024 | RAYSEARCH LABORATORIES AB RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. Open, Classified |
MUJ | None listed |
| Jun 10, 2022 | RAYSEARCH LABORATORIES AB RayStation 11B Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.