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eclipse treatment planning system
Varian Medical Systems
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiation therapy treatments. Key evidence highlights its accuracy in dose calculations and its use in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K133247 ↗
Decision Date
February 7, 2014
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System was cleared by the FDA via the 510(k) pathway on February 7, 2014. It is manufactured by Varian Medical Systems and is classified as a Class 2 device.
What It Is
The Eclipse Treatment Planning System is a software platform designed to assist clinicians in planning radiation therapy treatments. It calculates and optimizes dose distributions for various cancer types, ensuring precise targeting of tumors while sparing healthy tissue.
Clinical Applications
Common clinical scenarios for the Eclipse system include planning treatments for brain cancer, where accurate dose distribution is critical, and managing cases with metal implants, where dose calculation accuracy is challenged by imaging artifacts.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and technical reports. These studies span from 2022 to 2024, focusing on the system's dosimetric accuracy and clinical applications.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations in various clinical scenarios, including those involving metal implants and complex anatomical structures. The system's algorithms have been validated against Monte Carlo simulations, showing high concordance in dose distribution predictions.
Safety Profile
Reported complications include potential dose calculation errors in the presence of metal artifacts, which can affect treatment accuracy. However, the use of metal artifact reduction techniques has been shown to mitigate these issues.
Evidence Limitations
Current evidence is limited by the variability in study designs and the specific clinical contexts examined. Further research is needed to explore the system's performance across a broader range of tumor types and treatment settings.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The Eclipse system is indicated for use in planning radiation therapy treatments across various cancer types, including brain cancer and cases involving metal implants.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and effective treatment planning, particularly in complex scenarios involving metal artifacts and heterogeneous tissues.
What complications have been reported?
Safety data indicate potential dose calculation errors due to metal artifacts, though these can be mitigated with appropriate imaging techniques.
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.