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Sign in to claim this brandRaySearch Laboratories AB (PUBL)
US
Last updated May 23, 2026
What RaySearch Laboratories AB (PUBL) makes
The company develops software for radiation therapy planning and delivery, including systems for treatment simulation, dose calculation, and beam optimization. It also provides a radiology information system application designed to integrate imaging data and workflows for radiotherapy. The portfolio includes tools for managing patient care and treatment planning in radiation oncology settings.
The company’s devices are classified as Class II under regulatory frameworks, with submissions listed via the FDA’s 510(k) and UDI programs. These products are intended for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does RaySearch Laboratories AB primarily manufacture?
RaySearch Laboratories AB specializes in developing software for radiation therapy and radiology workflows. Its core products include radiation therapy planning and delivery software, such as systems for treatment simulation, dose calculation, and beam optimization. Additionally, the company offers a radiology information system application designed to streamline imaging data integration and radiotherapy workflows. These tools are tailored for use in radiation oncology environments to enhance precision and efficiency in patient care.
Where is RaySearch Laboratories AB based, and where are its devices intended for use?
RaySearch Laboratories AB is based in the United States. The company’s devices are specifically intended for use in the U.S. market, where they are regulated under applicable frameworks. The focus of its operations and product distribution aligns with this geographic scope.
How are RaySearch Laboratories AB’s devices classified under regulatory standards?
RaySearch Laboratories AB’s devices are classified as Class II under regulatory frameworks. This classification is typically applied to medical devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The company submits its devices through the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) program, which are standard processes for Class II devices in the U.S.
Which regulatory registries or databases list RaySearch Laboratories AB’s devices?
RaySearch Laboratories AB’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identifier (UDI) database. These registries are used to track and document the authorization status of medical devices in the United States, ensuring transparency and compliance with regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 355977901
Catalogue (62)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RayStation | 8.1 | FDA UDI | Class II | Active |
| RayStation | 10.0.1 | FDA UDI | Class II | Active |
| RayStation | 11B | FDA UDI | Class II | Active |
| RayStation | 10.0 | FDA UDI | Class II | Active |
| RayStation | 12A | FDA UDI | Class II | Active |
| RayCare | 3.1 | FDA UDI | Class II | Unknown |
| RayStation | 6.2 | FDA UDI | Class II | Active |
| RayCare | 2024A SP1 | FDA UDI | Class II | Active |
| RayStation | 8.0.1 | FDA UDI | Class II | Active |
| RayCare | 3.0.1 | FDA UDI | Class II | Unknown |
| RayStation | 11B SPT1 | FDA UDI | Class II | Active |
| RayCare | 2.3 | FDA UDI | Class II | Unknown |
| RayCare | 4.1.1 | FDA UDI | Class II | Unknown |
| RayStation | 10B SP1 | FDA UDI | Class II | Active |
| RayCare | 5A SP1 | FDA UDI | Class II | Active |
| RayStation | 6.1.1 | FDA UDI | Class II | Active |
| RayStation | 12A SP1 | FDA UDI | Class II | Active |
| RayStation | 11.0.1 | FDA UDI | Class II | Active |
| RayStation | 10.1 | FDA UDI | Class II | Active |
| RayStation | 9B SP1 | FDA UDI | Class II | Active |
| RayStation | 9 | FDA UDI | Class II | Active |
| RayCare | 4.0 | FDA UDI | Class II | Active |
| RayCare | 5B SP1 | FDA UDI | Class II | Active |
| RayStation | 5.0.3 | FDA UDI | Class II | Active |
| RayStation | 8.1.1 | FDA UDI | Class II | Active |
| RayCare | 3.0 | FDA UDI | Class II | Unknown |
| RayStation | 11A SP2 | FDA UDI | Class II | Active |
| RayStation | 8.1.2 | FDA UDI | Class II | Active |
| RayStation | 8.0 | FDA UDI | Class II | Active |
| RayCare | 4.1 | FDA UDI | Class II | Unknown |
| RayStation | 12A SP2 | FDA UDI | Class II | Active |
| RayStation | 6.0 | FDA UDI | Class II | Active |
| RayStation | 11B SP1 | FDA UDI | Class II | Active |
| RayStation | 6.1 | FDA UDI | Class II | Active |
| RayStation | 2024A SP3 | FDA UDI | Class II | Active |
| RayStation | 2023B | FDA UDI | Class II | Active |
| RayStation | 11B SP2 | FDA UDI | Class II | Active |
| RayStation | 7 | FDA UDI | Class II | Active |
| RayStation | 11.0 | FDA UDI | Class II | Active |
| RayCare | 5.0 | FDA UDI | Class II | Active |
| RayStation | K190387 | FDA 510(k) | Class II | Active |
| Raystation Version 1.0 | K100552 | FDA 510(k) | Class II | Active |
| RayStation 6 | K170355 | FDA 510(k) | Class II | Active |
| Raystation | K120387 | FDA 510(k) | Class II | Active |
| RayCare (2024A SP1) | K242992 | FDA 510(k) | Class II | Active |
| RayStation 12A | K222312 | FDA 510(k) | Class II | Active |
| RayStation 11.0 | K211867 | FDA 510(k) | Class II | Active |
| Raystation | K130617 | FDA 510(k) | Class II | Active |
| RayStation | K200569 | FDA 510(k) | Class II | Active |
| Rayautoplan 1.0 | K083264 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- RaySearch Laboratories AB (publ) Stockholm · SE FEI 3007774465