RayStation 12A
RaySearch Laboratories AB (publ)RayStation 12A by RaySearch Laboratories is a comprehensive radiation therapy treatment planning system that allows users to import patient images, define treatment targets, optimize and evaluate radiation treatment plans, and administer them. It supports multiple imaging modalities including CT, PET, and MR, enhancing precision in oncologic care by helping clinicians design effective and tailored radiation treatments while ensuring safety and accuracy.
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 12A is a treatment planning system consisting of multiple software applications (RayStation, RayPhysics, RayTreat) that use patient imaging data from CT, PET, and MR to plan and optimize radiation therapy treatments. It implements peer-reviewed algorithms for dose calculation (including Monte Carlo for electrons and photons, TG43 for brachytherapy) and plan parameter optimization. It supports features such as automatic field-in-field planning, eye planning with wedges, brachytherapy support for specific afterloaders, and dose tracking. The system stores data in Microsoft SQL databases and supports DICOM communication protocols.
Performance
Extensive software verification and validation testing were conducted, including dose engine validation for electron Monte Carlo dose calculation and brachytherapy planning. Validation confirmed that RayStation 12A achieves dose calculations that meet accuracy criteria compared to previous versions and independent reference systems. New features such as eye planning with wedges and automatic field in field planning were validated through system tests confirming correct dose distributions and safe operation. Safety and performance are supported by documented regression tests, acceptance criteria based on gamma analysis, and comparison to published data and independent Monte Carlo simulations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2022
8 months - 2
FDA Approval
3/29/2023
Other devices from RaySearch Laboratories AB (publ)
- RayStation 11B2022 • 510K
- RayStation 11.02021 • 510K
- RayStation 10.12021 • 510K
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