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modification to eclipse treatment planning system
Varian Medical Systems
Summary: The modification to the Eclipse Treatment Planning System by Varian Medical Systems is primarily used in radiotherapy planning. Key evidence highlights its role in improving treatment precision and reducing errors in data transfer.
FDA Clearance Information
Pathway
510K
Number
K071760 ↗
Decision Date
November 9, 2007
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The modification to the Eclipse Treatment Planning System was cleared by the FDA via the 510(k) pathway on November 9, 2007. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Eclipse Treatment Planning System is a software modification designed to enhance radiotherapy planning. It facilitates precise dose calculations and optimizes treatment delivery for various cancer types.
Clinical Applications
Commonly used in radiotherapy settings, this system aids in planning treatments for cancers such as prostate and breast cancer. It is particularly useful in scenarios requiring high precision, such as stereotactic body radiation therapy (SBRT).
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2022 to 2025, providing a comprehensive overview of the system's clinical applications.
Reported Outcomes
Published studies report improvements in treatment accuracy and efficiency, particularly in automated plan optimization and cardiac-sparing techniques. The system has shown potential in reducing recurrence rates and enhancing cosmetic outcomes in breast cancer treatments.
Safety Profile
Reported complications include potential errors in data transfer between treatment planning systems and oncology information systems, which could lead to treatment inaccuracies. However, no direct adverse patient outcomes have been highlighted.
Evidence Limitations
The evidence is limited by the variability in study designs and the potential for bias in retrospective analyses. Further research is needed to explore long-term outcomes and the integration of the system with other technologies.
Frequently Asked Questions
What are the clinical indications for modification to Eclipse Treatment Planning System?
The system is indicated for use in radiotherapy planning, particularly in cases requiring precise dose calculations and optimization, such as prostate and breast cancer treatments.
What outcomes have been reported in clinical studies?
Studies have reported enhanced treatment accuracy, reduced recurrence rates, and improved cosmetic outcomes in breast cancer treatments.
What complications have been reported?
Safety data indicate potential errors in data transfer between systems, though no direct adverse patient outcomes have been 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.