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eclipse treatment planning system 18 1
Varian Medical Systems
Summary: The Eclipse Treatment Planning System 18.1 by Varian Medical Systems is a device used for radiotherapy planning. It is FDA 510k cleared and supported by 12 studies, highlighting its role in improving treatment planning efficiency and accuracy.
FDA Clearance Information
Pathway
510K
Number
K242378 ↗
Decision Date
December 11, 2024
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System 18.1 received FDA 510k clearance on December 11, 2024. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Treatment Planning System 18.1 is a software platform designed for planning radiotherapy treatments. It facilitates precise dose calculations and treatment simulations, aiding clinicians in optimizing therapeutic outcomes.
Clinical Applications
Commonly used in radiotherapy departments, the Eclipse system assists in planning treatments for various cancers, including head and neck cancer. It is particularly beneficial in settings requiring complex dose calculations and treatment customization.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials and feasibility studies, conducted between 2024 and 2025. These studies explore the system's accuracy, feasibility, and potential to enhance radiotherapy planning.
Reported Outcomes
Published studies report that the Eclipse system improves workflow efficiency and treatment accuracy, particularly in resource-constrained environments. It has shown potential in dose escalation for head and neck cancer and in managing high-density materials in dental restorations.
Safety Profile
Reported complications include discrepancies in dose calculations when high-density materials are involved, such as dental amalgams. No significant adverse events were noted in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies focusing on specific clinical scenarios. Further research is needed to explore its integration into low-resource settings and its long-term impact on patient outcomes.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System 18.1?
The system is indicated for use in radiotherapy planning, particularly for cancers requiring precise dose calculations and treatment customization.
What outcomes have been reported in clinical studies?
Studies have reported improved workflow efficiency and treatment accuracy, with potential benefits in dose escalation and managing high-density materials.
What complications have been reported?
Safety data indicate potential discrepancies in dose calculations with high-density materials, but no significant adverse events were noted.
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.