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raystation
Raysearch Laboratories Ab
Summary: RayStation is a treatment planning system used primarily in radiotherapy. It is FDA-cleared and supported by 15 studies, highlighting its application in proton therapy and multi-criteria optimization.
FDA Clearance Information
Pathway
510K
Number
K120387 ↗
Decision Date
April 6, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation was cleared by the FDA via the 510(k) pathway on April 6, 2012. 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. It facilitates the planning of radiation doses for cancer patients, optimizing treatment delivery through advanced algorithms.
Clinical Applications
RayStation is commonly used in scenarios requiring precise radiation dose calculations, such as proton therapy and multi-criteria optimization in prostate cancer treatment. It aids in creating effective and personalized treatment plans.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2023 and 2024.
Reported Outcomes
Published studies report that RayStation effectively supports proton therapy planning and enhances treatment quality through multi-criteria optimization. It has been shown to improve plan quality and dosimetric outcomes in prostate radiotherapy.
Safety Profile
Reported complications include the need for accurate attenuation calculations through treatment couches, which can impact dose accuracy. No significant adverse events directly related to RayStation have been reported.
Evidence Limitations
Current evidence lacks long-term outcome data and comprehensive safety profiles. Further research is needed to validate findings across diverse patient populations and treatment settings.
Frequently Asked Questions
What are the clinical indications for RayStation?
RayStation is indicated for use in radiotherapy treatment planning, particularly in proton therapy and multi-criteria optimization for prostate cancer.
What outcomes have been reported in clinical studies?
Studies have reported improved treatment planning quality and dosimetric outcomes in proton and prostate radiotherapy using RayStation.
What complications have been reported?
Reported complications include challenges in dose calculation accuracy due to treatment couch attenuation, but no significant adverse events have been directly linked to RayStation.
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.