510(k) K190387 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Jun 19, 2019 |
| Received | Feb 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 8B, Software Version: 8.1.0.47.
2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8.
3. RayStation 8B Service Pack 2, Softw 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: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142
Software Version: RayStation 8B, 8B Service Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | None listed |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 9.0.0.113 and 9.0.1.142. 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 |
| Mar 22, 2023 | RAYSEARCH LABORATORIES AB Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12 Open, Classified |
MUJ | None listed |
| May 26, 2020 | RAYSEARCH LABORATORIES AB RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 Open, Classified |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 1, UDI #s 07350002010037,
07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | None listed |
| Mar 4, 2020 | RAYSEARCH LABORATORIES AB RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and Open, Classified |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system Terminated |
MUJ | None listed |
| Jan 27, 2020 | RAYSEARCH LABORATORIES AB RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0. Terminated |
MUJ | None listed |
| Nov 18, 2019 | RAYSEARCH LABORATORIES AB RayStation stand-alone software treatment planning system, Model Numbers 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 - Product Usage: RayStation is a software system designed for t Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.