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Modification to Eclipse Treatment Planning System
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 ?
510(k)
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.
FDA-Cleared Indications
- Used for treatment planning in radiation therapy.
- Supports calculation and evaluation of radiation dose distributions.
- Used to prepare radiation treatment plans for delivery by compatible radiotherapy equipment.
Clinical Applications
- External-beam radiation treatment planning.
- Dose calculation and evaluation for radiation therapy plans.
- Planning radiation treatments for different cancer sites when compatible with the clinical workflow and treatment equipment.
- Review and transfer of treatment-planning data for radiation treatment delivery.
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.
Practical Considerations
- This is software rather than an implanted or disposable device, so it does not have a physical size or patient-specific MRI safety classification.
- Use requires compatible radiation-therapy equipment, treatment-management systems, imaging data and a properly configured clinical workflow.
- Treatment plans require review and approval by qualified radiation oncology professionals before delivery.
- Accurate image registration, patient data entry, dose calculation and data transfer are important for safe use.
- Software version, supported treatment techniques and compatibility should be verified with the manufacturer and the treating institution.
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.