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raystation 6
Raysearch Laboratories Ab (Publ)
Summary: RayStation 6 is a treatment planning system used in radiotherapy. It supports AI-based auto-contouring and Monte Carlo dose calculations. Key evidence highlights its integration with other systems and validation for multiple LINACs.
FDA Clearance Information
Pathway
510K
Number
K170355 ↗
Decision Date
March 2, 2017
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation 6 was cleared by the FDA via the 510(k) pathway on March 2, 2017. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device.
What It Is
RayStation 6 is a treatment planning system designed for radiotherapy. It facilitates the planning and optimization of radiation doses for cancer treatment, utilizing advanced algorithms for dose calculation and AI-based auto-contouring.
Clinical Applications
RayStation 6 is commonly used in clinical scenarios involving radiotherapy planning, such as intensity-modulated radiation therapy (IMRT) and proton therapy. It is particularly useful in settings requiring precise dose calculations and automated contouring of target volumes.
Evidence Summary
The available literature includes 5 studies, ranging from 2023 to 2026, covering various aspects of RayStation 6's functionality, including AI integration and dose calculation validation. Study types include prospective and retrospective analyses.
Reported Outcomes
Published studies report that RayStation 6 effectively integrates AI-based auto-contouring with other treatment planning systems, improving workflow efficiency. The Monte Carlo dose calculation algorithm has been validated for accuracy across multiple LINACs, supporting its reliability in clinical settings.
Safety Profile
Reported complications include challenges in integrating AI tools into existing workflows, particularly when different platforms are used. No specific adverse events related to patient safety were noted in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to explore the full potential of AI integration and to establish standardized guidelines for its use across different platforms.
Frequently Asked Questions
What are the clinical indications for RayStation 6?
RayStation 6 is indicated for use in radiotherapy planning, including IMRT and proton therapy, where precise dose calculations and automated contouring are required.
What outcomes have been reported in clinical studies?
Studies have reported successful integration of AI-based auto-contouring and validation of dose calculation algorithms, enhancing workflow efficiency and accuracy.
What complications have been reported?
Reported complications include integration challenges with existing systems, but no direct patient safety issues were identified in the studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.