RaySearch Laboratories AB (PUBL) · Class II · Cleared Dec 22, 2025
| K-number | K252109 |
| Device name | RayStation (2024A SP3) |
| Applicant | RaySearch Laboratories AB (PUBL) |
| Product code | MUJ |
| Device class | Class II |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
RayStation 2024A SP3 is a software system for radiation therapy treatment planning and administration. It proposes treatment plans based on user input, which are then reviewed and approved by authorized users before being administered to patients. The system's functionality can be configured to meet individual clinic needs.
The device adds the RayTreat application for treatment delivery management compared to the predicate RayStation 2024A SP3 (without RayTreat). RayTreat is now session-focused with usability improvements and bug fixes since its last clearance in RayStation 11B. The device also includes validation for Hyperscan plans with Boron Carbide energy selector plates. Both versions use standard office PCs, Windows operating systems, and support CT, PET, and MR medical imaging.
Compliance demonstrated with IEC 61217 (radiotherapy equipment coordinates), IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), IEC 62083 (radiotherapy treatment planning systems safety), and IEC 81001-5-1 (health software security). Software verification and validation included unit testing, interoperability testing, system-level testing, cybersecurity testing, and regression testing.
View the full FDA submission: accessdata.fda.gov