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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 ?
510(k)
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.
FDA-Cleared Indications
- For use as a software system to support radiation therapy treatment planning.
- For calculating and evaluating radiation dose distributions and treatment plans.
- For use with radiation therapy treatment-planning workflows, including photon and proton therapy when configured and validated for those applications.
Clinical Applications
- Planning external-beam photon radiation therapy for cancer treatment.
- Planning proton beam radiation therapy when the appropriate system configuration and clinical workflow are available.
- Optimizing radiation dose distributions to help meet target-coverage and normal-tissue dose objectives.
- Reviewing and evaluating calculated treatment plans before clinical treatment delivery.
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.
Practical Considerations
- RayStation is software rather than an implanted or disposable medical device; it does not have a physical device size or vessel compatibility profile.
- Use requires compatible radiation-treatment equipment, imaging and patient-data systems, and a qualified radiation oncology team.
- Treatment plans require clinical review, quality assurance, and verification before radiation is delivered.
- MRI safety is not applicable to the software itself, although MRI data may be incorporated into planning when the imaging workflow and registration have been validated.
- The software does not independently determine whether radiation therapy is appropriate; treatment decisions remain with the treating radiation oncology team.
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.