RayStation 10.1
RaySearch Laboratories AB (publ)RayStation 10.1 is a software platform used to plan, analyze, and administer radiation therapy treatment and medical oncology. It helps clinicians generate and review treatment plans based on imaging data and user input, including advanced features like brachytherapy and ocular proton treatment planning. This system supports improved treatment accuracy and workflow efficiency for radiation oncology professionals.
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 10.1 consists of multiple applications for treatment planning, machine commissioning, treatment session management, and plan delivery. It includes fast and accurate dose and optimization engines, supports brachytherapy planning, ocular (eye) proton planning, and robust planning accounting for organ motion. The software shares design and platform with prior versions but adds medical oncology and administration capabilities.
Performance
Performance testing includes validation of brachytherapy dose calculations (TG43 formalism), medical oncology dose calculation methods, proton ocular treatment dose calculations, and robust planning accounting for organ motion. Testing consisted of system, unit, and subsystem tests, dose engine validation, and user validation in clinical settings, resulting in successful verification and validation meeting specifications.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/3/2021
3 months - 2
FDA Approval
6/29/2021
Other devices from RaySearch Laboratories AB (publ)
- RayStation 12A2023 • 510K
- RayStation 11B2022 • 510K
- RayStation 11.02021 • 510K
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