510(k) K222312 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation 12A
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Mar 29, 2023 |
| Received | Aug 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89
Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2
Product Descri Open, Classified |
MUJ | None listed |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 12A, Software Version: 13.0.0.1547.
2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144.
3. RayStation 12A 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: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338
Software Version: RayStation 12A, 12A Service Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 14.0.0.3338. 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.