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raystation 11 0
Raysearch Laboratories Ab (Publ)
Summary: RayStation 11.0 is a treatment planning system used in radiotherapy. It is primarily used for optimizing radiation dose delivery in cancer treatment. Key evidence highlights its application in proton therapy and MRI-guided radiotherapy.
FDA Clearance Information
Pathway
510K
Number
K211867 ↗
Decision Date
September 8, 2021
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation 11.0 was cleared by the FDA through the 510(k) pathway on September 8, 2021. It is manufactured by Raysearch Laboratories Ab (Publ) and is classified as a Class 2 device.
What It Is
RayStation 11.0 is a sophisticated treatment planning system designed for use in radiotherapy. It facilitates precise radiation dose calculations and optimizations, enhancing treatment accuracy and efficacy in oncology.
Clinical Applications
RayStation 11.0 is commonly used in clinical scenarios involving intensity-modulated proton therapy and MRI-guided radiotherapy. It supports clinicians in planning and delivering targeted radiation therapy for various cancers.
Evidence Summary
The available literature includes five studies, encompassing randomized controlled trials and retrospective analyses, published between 2021 and 2025. These studies explore the system's efficacy in different radiotherapy contexts.
Reported Outcomes
Published studies report that RayStation 11.0 enhances treatment precision in intensity-modulated proton therapy and MRI-guided radiotherapy. It improves organ-at-risk sparing and facilitates adaptive radiotherapy planning, particularly in prostate and bladder cancer treatments.
Safety Profile
Reported complications include challenges related to dose delivery accuracy at the tumor's distal edge and resource intensity in MRI-guided radiotherapy. However, no significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the need for further research on long-term outcomes and safety. Additionally, the studies often focus on specific cancer types, which may not generalize to all clinical scenarios.
Frequently Asked Questions
What are the clinical indications for RayStation 11.0?
RayStation 11.0 is indicated for use in planning and optimizing radiotherapy treatments, particularly in intensity-modulated proton therapy and MRI-guided radiotherapy.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved treatment precision and organ-at-risk sparing in proton and MRI-guided radiotherapy using RayStation 11.0.
What complications have been reported?
Safety data indicate challenges with dose delivery accuracy and resource intensity, 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.