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Panels › Radiology › Product code MUJ · Class 2

System, Planning, Radiation Therapy Treatment

Regulation 892.5050

13510(k)s in 12 months (258 all time)
13recalls in 12 months (270 all time)
257recalls that name a 510(k)
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Top companies in MUJ

Company510(k)sRecalls
Raysearch Laboratories AB7117
Elekta, Inc.246
Computerized Medical Systems, Inc.931
Varian Medical Systems337
Siemens Medical Solutions USA, Inc.136
Brainlab AG117
Varian Medical Systems, Oncology Systems117
Accuray Incorporated96
RaySearch Laboratories AB (PUBL)150
Nucletron131
DateFirm and productCodeLinked 510(k)
Jul 1, 2026RAYSEARCH LABORATORIES AB
RayCare 2024A SP4. Oncology Information Systems.
Open, Classified		 MUJK242992
Jul 1, 2026RAYSEARCH LABORATORIES AB
RayCare 2024A SP1. Oncology Information Systems.
Open, Classified		 MUJK242992
Feb 10, 2026Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan is a computer-based system designed for Leksel
Open, Classified		 MUJK173791
Feb 10, 2026Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamm
Open, Classified		 MUJK151666
Jan 16, 2026RAYSEARCH 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		 MUJNone listed
Jan 16, 2026RAYSEARCH 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		 MUJNone listed
Jan 16, 2026RAYSEARCH 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		 MUJNone listed
Jan 16, 2026RAYSEARCH 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		 MUJNone listed
Jan 16, 2026RAYSEARCH 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		 MUJK240398
Jan 16, 2026RAYSEARCH 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		 MUJK222312
Jan 16, 2026RAYSEARCH 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		 MUJK220141
Jan 16, 2026RAYSEARCH 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		 MUJK211867
Jan 16, 2026RAYSEARCH LABORATORIES AB
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Open, Classified		 MUJK210645
Sep 16, 2025Philips Medical Systems (Cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)0088
Open, Classified		 MUJK041577
K090808 +1
Sep 2, 2025RAYSEARCH 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		 MUJK240398
Sep 2, 2025RAYSEARCH 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		 MUJK171536
Sep 2, 2025RAYSEARCH 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		 MUJK222312
Sep 2, 2025RAYSEARCH 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		 MUJK220141
Sep 2, 2025RAYSEARCH 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		 MUJK211867
Sep 2, 2025RAYSEARCH 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		 MUJK210645
Sep 2, 2025RAYSEARCH 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		 MUJK200569
Sep 2, 2025RAYSEARCH 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		 MUJK190387
Sep 2, 2025RAYSEARCH 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		 MUJK180379
Aug 1, 2025Philips Medical Systems (Cleveland) Inc
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Open, Classified		 MUJK170086
Feb 19, 2025RAYSEARCH 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		 MUJK141860
Feb 19, 2025RAYSEARCH 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		 MUJK160093
Feb 19, 2025RAYSEARCH 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		 MUJK170355
Feb 19, 2025RAYSEARCH 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		 MUJK171536
Feb 19, 2025RAYSEARCH 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		 MUJK222312
Feb 19, 2025RAYSEARCH 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		 MUJK220141
Feb 19, 2025RAYSEARCH 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		 MUJK211867
Feb 19, 2025RAYSEARCH 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		 MUJK210645
Feb 19, 2025RAYSEARCH 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		 MUJK200569
Feb 19, 2025RAYSEARCH 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		 MUJK190387
Feb 19, 2025RAYSEARCH 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		 MUJK180379
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJNone listed
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK222312
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK222312
May 1, 2024RAYSEARCH 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		 MUJK220141
May 1, 2024RAYSEARCH 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		 MUJK211867
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK210645
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK200569
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK200569
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK190387
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK190387
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJK180379
May 1, 2024RAYSEARCH LABORATORIES AB
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Open, Classified		 MUJNone listed
Apr 5, 2024RAYSEARCH 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		 MUJK190387
K200569 +4
Dec 8, 2023Bebig Isotopentechnik Gmbh
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Open, Classified		 MUJK141900
Nov 1, 2023RAYSEARCH 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		 MUJK200487

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