510(k) K200569 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Sep 24, 2020 |
| Received | Mar 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 9B, Software Version: 9.1.0.933.
2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483.
3. RayStation 10A, Software Version 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: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10
Software Version: RayStation 9B, 9B Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. 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 29, 2023 | RaySearch America Inc Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10 Terminated |
MUJ | None listed |
| Jun 1, 2022 | RAYSEARCH LABORATORIES AB RayStation 9B SP1. For radiation treatment planning. Terminated |
MUJ | None listed |
| Jun 8, 2021 | RAYSEARCH LABORATORIES AB RayStation (Radiation Treatment Planning System) :
RayStation 9A, 9B, 9B SP1, 10A, 10A
SP1, 10B and 11A, in combination with RayCare
Model Numbers/ UDI:
RayStation 9.0 (9.0.0.113) 07350002010174;
Ra Terminated |
MUJ | None listed |
| Apr 21, 2021 | RAYSEARCH LABORATORIES AB RayStation (Treatment Planning System)
Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0. Terminated |
MUJ | None listed |
| Apr 7, 2021 | RAYSEARCH LABORATORIES AB RayStation standalone software radiation therapy treatment planning system.
Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs Terminated |
MUJ | None listed |
| Mar 25, 2021 | RAYSEARCH LABORATORIES AB RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) Open, Classified |
MUJ | None listed |
| Feb 22, 2021 | RAYSEARCH LABORATORIES AB RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system Terminated |
MUJ | None listed |
| Nov 11, 2020 | RAYSEARCH LABORATORIES AB RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Mod Terminated |
MUJ | None listed |
| Oct 8, 2020 | RAYSEARCH LABORATORIES AB RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.