đź“Š Evidence-Based Reference
eclipse treatment planning system v16 0
Varian Medical Systems
Summary: The Eclipse Treatment Planning System v16.0 by Varian Medical Systems is a software tool used for radiation therapy planning. It is primarily used to optimize treatment plans for various cancer types. Key evidence highlights its application in lung SBRT and stereotactic radiosurgery.
FDA Clearance Information
Pathway
510K
Number
K200608 ↗
Decision Date
April 3, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System v16.0 received FDA clearance through the 510(k) pathway on April 3, 2020. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Treatment Planning System v16.0 is a software platform designed to assist clinicians in creating precise radiation therapy plans. It is used to calculate and optimize dose distributions for cancer treatment, ensuring effective and safe delivery of radiation.
Clinical Applications
Common clinical scenarios for the Eclipse system include planning for lung stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS). It is utilized in settings where precise dose calculation and delivery are critical, such as in treating brain and lung tumors.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted up to 2025. These studies explore the system's efficacy in different therapeutic contexts.
Reported Outcomes
Published studies report that the Eclipse system enhances planning efficiency and accuracy, particularly in lung SBRT and SRS. The hybrid dynamic conformal arc-volumetric modulated arc therapy (hDCA-VMAT) technique showed improved delivery robustness. Additionally, the enhanced leaf model in newer versions improved dose calculation accuracy.
Safety Profile
Reported complications include potential discrepancies in dose calculations due to CT number variations and elemental composition differences in tissue-equivalent materials. However, no significant adverse events directly linked to the system's use were highlighted in the studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the potential for user-dependent variability in dose calculations. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System v16.0?
The system is indicated for use in radiation therapy planning, particularly in lung SBRT and stereotactic radiosurgery.
What outcomes have been reported in clinical studies?
Studies have reported improved planning efficiency and accuracy, especially in lung SBRT and SRS, with enhanced dose calculation models.
What complications have been reported?
Safety data indicate potential dose calculation discrepancies due to CT number and material composition differences, but no major adverse events 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.