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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 used for advanced radiotherapy planning. Key evidence highlights its role in automated and adaptive radiotherapy planning, with studies demonstrating its feasibility and accuracy.
FDA Clearance Information
Pathway
510K
Number
K091492 ↗
Decision Date
June 18, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System modification by Varian Medical Systems was cleared via the FDA 510(k) pathway on June 18, 2009. It is classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Treatment Planning System is a software platform designed for planning radiotherapy treatments. It allows clinicians to create precise treatment plans by integrating imaging data and optimizing radiation dose delivery to target tissues while sparing healthy tissues.
Clinical Applications
Common clinical scenarios for the Eclipse system include planning for whole brain radiotherapy, stereotactic body radiation therapy (SBRT), and adaptive radiotherapy. It is particularly useful in cases requiring precise dose delivery and sparing of critical structures.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies. These studies span from 2023 to 2025 and explore various applications of the Eclipse system in radiotherapy planning.
Reported Outcomes
Published studies report that the Eclipse system facilitates automated and adaptive radiotherapy planning, improving the accuracy of dose delivery and sparing of critical structures. It has been shown to be effective in planning for hippocampal sparing whole brain radiotherapy and cardiac-sparing accelerated partial breast irradiation.
Safety Profile
Reported complications include potential inaccuracies in image registration and contour propagation, which are critical for adaptive radiotherapy. However, no significant adverse events have been consistently reported across studies.
Evidence Limitations
Evidence gaps include a need for larger, long-term studies to validate the clinical outcomes and safety of the Eclipse system modifications. Some studies are limited by small sample sizes and retrospective designs.
Frequently Asked Questions
What are the clinical indications for modification to Eclipse treatment planning system?
The system is indicated for use in planning radiotherapy treatments, including whole brain radiotherapy, SBRT, and adaptive radiotherapy, where precise dose delivery is required.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in dose delivery and sparing of critical structures, particularly in hippocampal sparing whole brain radiotherapy and cardiac-sparing breast irradiation.
What complications have been reported?
Safety data indicate potential issues with image registration and contour propagation accuracy, but no significant adverse events have been consistently 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.