510(k) K211867 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 11.0
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Sep 8, 2021 |
| Received | Jun 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4.
Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3.
Radiation Therapy Treatment P Open, Classified |
MUJ | None listed |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 11A, Software Version: 11.0.0.951.
2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29.
3. RayStation 11A Service Pack 2 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: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15
Software Revisions: RayStation 11A and 11A Servic Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. 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 |
| Feb 11, 2022 | RaySearch America Inc RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs:
RayStation 4.0 (4.0.0.14) to
RayStation 5 Service Pack 2 (5.0.2.35),
RayStation 5 Service Pack 3 (5.0.3.17),
RayStation 6/Ray Open, Classified |
MUJ | None listed |
| Dec 30, 2021 | RAYSEARCH LABORATORIES AB RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy.
Software Version: 6.0.0.24 , 6.1.0.26 , 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 Open, Classified |
MUJ | None listed |
| Sep 22, 2021 | RAYSEARCH LABORATORIES AB RayStation/RayPlan versions 4 - 11A, including service packs.
Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.1 Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.