14 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Redsense FOE
Device
EU MDR
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Eu Md Class 1
·Redsense Medical AB·On the market·10 countries
Redsense Alarm fiber optic extension (FOE)
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Redsense Medical AB·1 device
EOE Eyewear AB
Importer
🇸🇪 Sweden
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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 Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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 Treatment Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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: Radiation Therapy Treatment Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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 Planning System
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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 Description: Radiation Therapy Treatment Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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. Radiation Therapy Treatment Planning System
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
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
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·July 1, 2020
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 1, 2016