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raystation
Raysearch Laboratories Ab (Publ)
Summary: RayStation is a treatment planning system used in radiotherapy, particularly for proton therapy. Key evidence highlights its role in optimizing treatment plans and comparing imaging frameworks.
FDA Clearance Information
Pathway
510K
Number
K190387 ↗
Decision Date
June 19, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation was cleared by the FDA through the 510(k) pathway on June 19, 2019. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayStation is a comprehensive treatment planning system designed for radiotherapy. It facilitates the planning and optimization of treatment plans, particularly for proton therapy, by providing advanced algorithms and imaging frameworks.
Clinical Applications
RayStation is commonly used in clinical scenarios involving external beam radiation therapy, including proton therapy. It aids in treatment planning by optimizing energy layers and spot selection, crucial for effective dose delivery.
Evidence Summary
The available literature includes 15 studies, with a mix of study types such as RCTs and prospective studies, published between 2023 and 2024. These studies explore various aspects of RayStation's functionality and clinical applications.
Reported Outcomes
Published studies report that RayStation effectively optimizes treatment plans for proton therapy, improving plan quality and dosimetric accuracy. Comparative studies highlight its multi-criteria optimization capabilities, particularly in prostate radiotherapy.
Safety Profile
Reported complications include challenges in accurately modeling treatment couch attenuation, which can affect dose calculations. However, no significant adverse events have been directly attributed to the use of RayStation in the available studies.
Evidence Limitations
Current evidence is limited by the lack of long-term outcome data and direct comparisons with other treatment planning systems. Further research is needed to validate its efficacy across diverse patient populations and treatment modalities.
Frequently Asked Questions
What are the clinical indications for RayStation?
RayStation is indicated for use in radiotherapy treatment planning, particularly for proton therapy and other external beam radiation therapies.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved treatment plan quality and dosimetric accuracy, especially in proton therapy and prostate radiotherapy.
What complications have been reported?
Safety data indicate challenges in modeling treatment couch attenuation, but no significant adverse events have been reported.
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.