RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (publ)RayStation and RayPlan are advanced software systems designed for radiation therapy planning and medical oncology. They help clinicians propose and optimize treatment plans based on patient imaging data, improving the delivery of safe and effective radiation doses. The software supports a range of radiotherapy techniques, including photon and proton therapies, and incorporates sophisticated dose calculation and optimization algorithms to tailor treatments to individual patients' needs.
Intended Use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
Technology
RayStation is a standalone software platform that integrates treatment planning modules including dose calculation algorithms (Monte Carlo, Collapsed Cone, Pencil Beam), optimization engines, and support for multiple treatment modalities such as photon, proton, and brachytherapy. It uses Microsoft SQL databases for patient and machine data storage and provides tools for 3D visualization, beam commissioning, plan evaluation, and quality assurance.
Performance
Verification and validation testing included unit, integration, and system testing, dose engine validation against measurements and independent TPS, usability testing in clinical environments, and cybersecurity evaluation. Dose accuracy was validated with gamma evaluation criteria and clinical workflows verified. Testing confirmed the device is as safe and effective as its predicate, RayStation 12A (K222312).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/9/2024
1 year, 1 months - 2
FDA Approval
4/4/2025
Other devices from RaySearch Laboratories AB (publ)
- RayCare (2024A SP1)2025 • 510K
- RayStation 12A2023 • 510K
- RayStation 11B2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.