RayStation 11B
RaySearch Laboratories AB (publ)RayStation 11B is a radiation therapy treatment planning software that helps clinicians create, analyze, and manage radiation treatment plans for cancer patients. The software integrates imaging data, including CT and CBCT, to compute radiation doses accurately and supports the administration of treatments, improving clinical workflow and patient care.
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 11B is built on the same platform as its predicate device RayStation 11.0 but includes new features such as EQD2 dose computation, generation of synthetic CT from CBCT using two new algorithms, and computation of dose-weighted Linear Energy Transfer (LET) for proton and light ion plans. The system includes multiple applications for treatment planning, commissioning, and treatment administration.
Performance
Verification and validation activities included system tests, risk analysis, unit and subsystem testing, dose engine validation, and user validation in cooperation with cancer clinics. New features were validated with clinical and user site tests demonstrating dose computation accuracy adequate for clinical use. Overall, RayStation 11B met specifications and performed as safely and effectively as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/18/2022
2 months - 2
FDA Approval
4/15/2022
Other devices from RaySearch Laboratories AB (publ)
- RayStation 12A2023 • 510K
- RayStation 11.02021 • 510K
- RayStation 10.12021 • 510K
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