RayStation 11.0
RaySearch Laboratories AB (publ)RayStation 11.0 is a software system used in radiation therapy and medical oncology for planning, analyzing, and administering treatment plans. It helps clinicians design and optimize radiation treatments accurately based on the patient's medical imaging data, enhancing treatment effectiveness and safety.
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 11.0 consists of multiple applications for treatment planning, commissioning treatment and imaging machines, and sending plans to treatment delivery devices. It supports dose calculation using validated photon dose engines (collapsed cone and Monte Carlo) for CyberKnife M6/S7 machines. It has a modern user interface, fast and accurate dose and optimization engines built on the same software platform as its predicate device version 10.1.
Performance
Verification and validation activities included system tests, risk analysis-based tests, unit and subsystem testing, dose engine validation, and user validation in cooperation with cancer clinics. Validation showed dose computation is adequate for clinical use and that RayStation 11.0 is as safe and effective as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/16/2021
2 months - 2
FDA Approval
9/8/2021
Other devices from RaySearch Laboratories AB (publ)
- RayStation 12A2023 • 510K
- RayStation 11B2022 • 510K
- RayStation 10.12021 • 510K
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