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raystation
Raysearch Laboratories Ab
Summary: RayStation is a treatment planning system used primarily in radiation therapy. It is FDA-cleared and supported by 15 studies, focusing on its application in proton therapy and multi-criteria optimization.
FDA Clearance Information
Pathway
510K
Number
K141860 ↗
Decision Date
October 23, 2014
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation was cleared by the FDA through the 510(k) pathway on October 23, 2014. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device under product code MUJ.
What It Is
RayStation is a treatment planning system designed for radiation therapy. It facilitates the planning and optimization of radiation doses for cancer treatment, including proton and photon therapies.
Clinical Applications
RayStation is commonly used in clinical scenarios involving radiation therapy for cancer patients. It is particularly noted for its application in proton therapy and multi-criteria optimization for treatment planning.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, retrospective, and case series designs, 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 supports treatment planning in proton therapy and enhances plan quality through multi-criteria optimization. It has been shown to improve dosimetric outcomes in prostate cancer radiotherapy and automate planning for multiple anatomical sites.
Safety Profile
Reported complications include technical challenges in implementing automated planning and the need for further validation of new algorithms. No significant adverse events directly related to the device were reported in the studies.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the need for larger sample sizes in some studies. Further research is needed to validate new algorithms and automated planning approaches across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for RayStation?
RayStation is indicated for use in radiation therapy planning, particularly in proton therapy and multi-criteria optimization for cancer treatment.
What outcomes have been reported in clinical studies?
Studies report improved dosimetric outcomes and enhanced plan quality in prostate cancer radiotherapy and automated planning for multiple anatomical sites.
What complications have been reported?
Reported complications include technical challenges in automated planning and the need for further validation of new algorithms.
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.