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raystation
Raysearch Laboratories Ab
Summary: RayStation is a treatment planning system used in radiotherapy, primarily for proton therapy. Key evidence highlights its role in optimizing treatment plans and comparing imaging frameworks.
FDA Clearance Information
Pathway
510K
Number
K130617 ↗
Decision Date
May 10, 2013
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation was cleared by the FDA through the 510(k) pathway on May 10, 2013. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device.
What It Is
RayStation is a treatment planning system designed for radiotherapy, including proton therapy. It facilitates the creation of optimized treatment plans by integrating advanced algorithms and imaging techniques.
Clinical Applications
RayStation is commonly used in clinical scenarios involving external beam radiation therapy, particularly with proton beams. It aids in treatment planning by optimizing dose distribution and managing complex treatment parameters.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2023 to 2024, focusing on treatment planning and optimization in radiotherapy.
Reported Outcomes
Published studies report that RayStation enhances treatment planning quality, particularly in proton therapy. It offers improved dose distribution and optimization capabilities compared to conventional systems. Studies also highlight its effectiveness in multi-criteria optimization for prostate radiotherapy.
Safety Profile
Reported complications include challenges in accurately modeling treatment couches and potential discrepancies in dose calculations. However, no significant adverse events directly related to RayStation's use were identified in the studies.
Evidence Limitations
Evidence gaps include a need for more extensive comparative studies with other treatment planning systems. Some studies lack long-term follow-up data, and further research is needed to validate findings across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for RayStation?
RayStation is indicated for use in treatment planning for radiotherapy, including proton therapy and multi-criteria optimization for various cancers.
What outcomes have been reported in clinical studies?
Studies report improved treatment planning quality, enhanced dose distribution, and effective optimization in proton and prostate radiotherapy.
What complications have been reported?
Safety data indicate potential issues with dose calculation accuracy and modeling of treatment couches, but no major adverse events were 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.