📊 Evidence-Based Reference
Raystation Version 1 0
Raysearch Laboratories Ab
Summary: RayStation Version 1 0 is a treatment planning system used in radiotherapy. It is primarily used for dose calculation and optimization in various radiotherapy modalities. Key evidence includes validation of its Monte Carlo dose engine for proton therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K100552 ↗
Decision Date ?
March 12, 2010
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
RayStation Version 1 0 was cleared by the FDA through the 510(k) pathway on March 12, 2010. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device.
What It Is
RayStation Version 1 0 is a treatment planning system designed to assist clinicians in planning radiotherapy treatments. It provides tools for dose calculation, optimization, and evaluation, enhancing the precision of radiotherapy delivery.
FDA-Cleared Indications
- Treatment planning for radiotherapy.
- Calculation and optimization of radiation dose distributions for supported radiotherapy modalities.
- Evaluation of planned radiation treatments, including complex treatment plans.
Clinical Applications
- Planning external-beam radiation treatments for patients with cancer.
- Calculating radiation dose distributions for treatment-plan evaluation.
- Optimizing treatment plans to shape radiation dose around target volumes and nearby normal tissues.
- Planning proton therapy treatments when the applicable software, hardware, and clinical workflow are validated.
- Planning treatments involving very high-energy electron beams when supported by the installed system configuration.
Evidence Summary
The available literature includes four studies, ranging from 2016 to 2026, focusing on dose calculation and quality assurance in radiotherapy. These studies include validation and comparison of treatment planning methodologies.
Reported Outcomes
Published studies report successful validation of RayStation's Monte Carlo dose engine for proton therapy, ensuring accurate dose calculations. Additionally, the system's capability in planning very high-energy electron beams has been demonstrated, showing comparable efficacy to volumetric modulated arc therapy.
Safety Profile
Reported complications include potential discrepancies in dose calculation under certain conditions, as highlighted in quality assurance studies. However, no significant adverse events were directly attributed to the use of RayStation Version 1 0 in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to explore long-term outcomes and safety in diverse clinical settings.
Practical Considerations
- This is software rather than an implanted or disposable medical device; it has no physical device size, vascular access site, or MRI safety classification.
- Use requires compatible radiation-treatment equipment, imaging data, dose-calculation algorithms, and a clinically validated workflow.
- Treatment plans should undergo appropriate physician review, quality assurance, and independent checks before radiation delivery.
- The available functions depend on the installed version, licensed modules, treatment modality, and facility-specific validation.
- The system should not be used as the sole basis for treatment decisions; clinical judgment and applicable radiation-safety procedures remain necessary.
Frequently Asked Questions
What are the clinical indications for RayStation Version 1 0?
RayStation Version 1 0 is indicated for use in planning radiotherapy treatments, particularly in scenarios requiring precise dose calculations such as proton therapy and high-energy electron beam therapy.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful validation of the Monte Carlo dose engine for proton therapy and effective planning capabilities for very high-energy electron beams.
What complications have been reported?
Reported complications include potential discrepancies in dose calculation, as noted in quality assurance studies, but no significant adverse events were directly linked to the device.
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.