Company ยท SE
RAYSEARCH LABORATORIES AB
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2014. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
117recalls (11 in 12 months)
111recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 124 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2014 | K141860 | RAYSTATION Raysearch Laboratories AB, SE | MUJ |
| May 15, 2014 | K140187 | RAY STATION Raysearch Laboratories AB, SE | MUJ |
| May 10, 2013 | K130617 | RAYSTATION Raysearch Laboratories AB, SE | MUJ |
| Apr 6, 2012 | K120387 | RAYSTATION Raysearch Laboratories AB, SE | MUJ |
| Mar 12, 2010 | K100552 | RAYSTATION VERSION 1.0 Raysearch Laboratories AB, SE | MUJ |
| Jan 22, 2009 | K083264 | RAYAUTOPLAN 1.0 Raysearch Laboratories AB, SE | MUJ |
| Oct 22, 2008 | K082221 | RAYDOSE Raysearch Laboratories AB, SE | MUJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | RAYSEARCH LABORATORIES AB RayCare 2024A SP4. Oncology Information Systems. Open, Classified |
MUJ | K242992 |
| Jul 1, 2026 | RAYSEARCH LABORATORIES AB RayCare 2024A SP1. Oncology Information Systems. Open, Classified |
MUJ | K242992 |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 17.0.0, 17.0.1
Software Version: RayStation v2025, RayStation v2025 SP1
Product Description: Radiation Therapy Treatment P Open, Classified |
MUJ | None listed |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 16.0.0
Software Version: RayStation 2024B
Product Description: Radiation Therapy Treatment Planning System
Component: No Open, Classified |
MUJ | None listed |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 15.2.0, 15.1.3
Software Version: RayStation 2024A SP1, RayStation 2024A SP2
Product Description: Radiation Therapy Treatme Open, Classified |
MUJ | None listed |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 10.1.1
Software Version: RayStation 10B SP1
Product Description: Radiation Therapy Treatment Planning System
Component: No Open, Classified |
MUJ | None listed |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB Brand Name: RayStation
Product Name: RayStation/RayPlan
Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3
Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3
Product Description: Rad Open, Classified |
MUJ | K240398 |
| 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 | K222312 |
| Jan 16, 2026 | RAYSEARCH LABORATORIES AB RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0.
Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1.
Open, Classified |
MUJ | K220141 |
| 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 | K211867 |
| 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 | K210645 |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 2023B, Software Version: 14.0.0.3338.
2. RayStation 2024A, Software Version: 15.0.0.430.
3. RayStation 2024A SP3, Software Version Open, Classified |
MUJ | K240398 |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2.
2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7.
3. RayStation 6 Service Pa Open, Classified |
MUJ | K171536 |
| 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 | K222312 |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 11B, Software Version: 12.0.0.932.
2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221.
3. RayStation 11B Service Pack Open, Classified |
MUJ | K220141 |
| 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 | K211867 |
| 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 | K210645 |
| 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 | K200569 |
| 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 | K190387 |
| Sep 2, 2025 | RAYSEARCH LABORATORIES AB RayStation with the following product descriptions:
1. RayStation 7, Software Version: 7.0.0.19.
2. RayStation 8A, Software Version: 8.0.0.61.
3. RayStation 8A Service Pack 1, Software Version: 8. Open, Classified |
MUJ | K180379 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7
Software Version: RayStation 4.5.1, 4. Open, Classified |
MUJ | K141860 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 5.0.2.35 and 5.0.3.17
Software Version: RayStation 5 Service Pack 2 and 3 Open, Classified |
MUJ | K160093 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 6.0.0.24
Software Version: RayStation 6 Open, Classified |
MUJ | K170355 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6
Software Version: RayStation 6 Service Pack 1, 2 and 3 Open, Classified |
MUJ | K171536 |
| 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 | K222312 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119
Software Version: RayStation 11B an Open, Classified |
MUJ | K220141 |
| 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 | K211867 |
| 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 | K210645 |
| 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 | K200569 |
| 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 | K190387 |
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System.
Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10
Software Version: RayStation 7, 8A and 8A Service Pack 1 Open, Classified |
MUJ | K180379 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 15.0.0.430. 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 | K222312 |
| 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 | K222312 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | K220141 |
| 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 | K211867 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | K210645 |
| 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 | K200569 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | K200569 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | K190387 |
| 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 | K190387 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. Open, Classified |
MUJ | K180379 |
| May 1, 2024 | RAYSEARCH LABORATORIES AB RayStation 7.0.0.19. 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 | K190387 K200569 +4 |
| Nov 1, 2023 | RAYSEARCH LABORATORIES AB RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Open, Classified |
MUJ | K200487 |
| Aug 25, 2023 | RAYSEARCH LABORATORIES AB RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and trea Open, Classified |
MUJ | K200487 |
| 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 | K190387 |
| Jun 10, 2022 | RAYSEARCH LABORATORIES AB RayStation 11B Terminated |
MUJ | K220141 |
| Jun 1, 2022 | RAYSEARCH LABORATORIES AB RayStation 9B SP1. For radiation treatment planning. Terminated |
MUJ | K200569 |
| 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 | K211867 |
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