RayStation
RaySearch Laboratories AB (publ)RayStation is a software system designed to assist radiation therapy staff in planning and analyzing radiation treatments. It uses patient imaging data from CT, PET, and MRI scans to create detailed treatment plans that optimize radiation delivery while protecting healthy tissue. The system includes features like image fusion, contouring, dose computation, and machine learning to optimize and adapt treatment plans efficiently, helping clinicians deliver precise and effective cancer therapy.
Intended Use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Technology
RayStation 8.1 is a radiation therapy treatment planning system that includes functionalities such as image fusion (CT, PET, MRI), contouring tools, collapsed cone convolution dose computation, 4D data compatibility, treatment console interfacing, machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation, and deformable registration within one software platform.
Performance
Performance testing included verification and validation of the software, demonstrating that RayStation 8.1 is as safe and effective as the predicate device RayStation 7.0. Testing showed usability, computational speed, and connectivity improvements while maintaining safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/19/2019
4 months - 2
FDA Approval
6/19/2019
Other devices from RaySearch Laboratories AB (publ)
- RayStation 12A2023 • 510K
- RayStation 11B2022 • 510K
- RayStation 11.02021 • 510K
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