đź“Š Evidence-Based Reference
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 radiotherapy planning. It is FDA 510(k) cleared and supported by 15 studies, highlighting its role in optimizing treatment plans.
FDA Clearance Information
Pathway
510K
Number
K071873 ↗
Decision Date
August 9, 2007
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System modification by Varian Medical Systems was cleared through the FDA 510(k) pathway on August 9, 2007. It is classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Treatment Planning System modification is a software tool designed to enhance radiotherapy planning. It assists clinicians in creating precise treatment plans by optimizing radiation dose delivery to target tissues while minimizing exposure to surrounding healthy tissues.
Clinical Applications
This device is commonly used in clinical scenarios involving complex radiotherapy treatments, such as stereotactic body radiation therapy (SBRT) and accelerated partial breast irradiation (APBI). It aids in the precise delivery of radiation therapy, improving treatment accuracy and patient outcomes.
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 device's clinical utility and performance.
Reported Outcomes
Published studies report that the Eclipse Treatment Planning System modification improves the accuracy of radiotherapy plans, enhances tumor control, and reduces radiation exposure to healthy tissues. It has been shown to facilitate automated plan optimization and improve dosimetric outcomes in various 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 events related to the device's use were identified in the studies.
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 evaluate long-term outcomes and to standardize protocols across different clinical settings.
Frequently Asked Questions
What are the clinical indications for modification to Eclipse Treatment Planning System?
The device is indicated for use in radiotherapy planning, particularly in complex treatments like SBRT and APBI, where precise radiation delivery is crucial.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in treatment plans, enhanced tumor control, and reduced radiation exposure to healthy tissues.
What complications have been reported?
Safety data indicate potential errors in data transfer between systems, but no direct adverse events related to the device itself were 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.