510(k) K210645 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 10.1
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Jun 29, 2021 |
| Received | Mar 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB RayStation/RayPlan. Model/Catalog Number: 10.1.
Software Version: RayStation/RayPlan 10B.
Radiation Therapy Treatment Planning System Open, Classified |
MUJ | None listed |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 10B, Software Version: 10.1.0.613.
2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54.
Product Description: Radiation 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: 10.1.0.613 and 10.1.1.54
Software Version: RayStation 10B and 10B Service Pack 1 Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 10.1.0.613 and 10.1.1.54. 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 |
| Sep 9, 2021 | RAYSEARCH LABORATORIES AB TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A.
Build Numbers:
6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.