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raystation
Raysearch Laboratories Ab (Publ)
Summary: RayStation is a treatment planning system used in radiation therapy, primarily for proton therapy. Key evidence highlights its role in optimizing treatment plans and its comparative effectiveness with other systems.
FDA Clearance Information
Pathway
510K
Number
K200569 ↗
Decision Date
September 24, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation was cleared by the FDA via the 510(k) pathway on September 24, 2020. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayStation is a treatment planning system designed for use in radiation therapy, particularly in proton therapy. It provides tools for optimizing treatment plans and calculating dose distributions.
Clinical Applications
RayStation is commonly used in clinical scenarios involving proton therapy, where precise dose distribution is critical. It aids in planning treatments for various cancers, including prostate cancer.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials and comparative studies, published between 2023 and 2024. These studies focus on the system's optimization capabilities and comparative effectiveness.
Reported Outcomes
Published studies report that RayStation effectively optimizes treatment plans for proton therapy, improving dosimetric outcomes. Comparative studies indicate its multi-criteria optimization function enhances plan quality compared to other systems.
Safety Profile
Reported complications include potential inaccuracies in dose calculation if the treatment couch is not properly accounted for. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
Current evidence lacks long-term outcome data and comprehensive safety profiles. Further research is needed to assess its effectiveness across diverse patient populations and treatment settings.
Frequently Asked Questions
What are the clinical indications for RayStation?
RayStation is indicated for use in radiation therapy treatment planning, particularly in proton therapy for cancer treatment.
What outcomes have been reported in clinical studies?
Studies report improved dosimetric outcomes and enhanced plan quality with RayStation's optimization functions.
What complications have been reported?
Safety data indicate potential dose calculation inaccuracies if the treatment couch is not properly accounted for.
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.