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eclipse treatment planning system v18 0
Varian Medical Systems
Summary: The Eclipse Treatment Planning System v18.0 by Varian Medical Systems is a sophisticated tool for radiation therapy planning, cleared by the FDA. Key evidence highlights its dosimetric sensitivity and planning efficiency in complex radiotherapy scenarios.
FDA Clearance Information
Pathway
510K
Number
K230557 ↗
Decision Date
May 26, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System v18.0 received FDA clearance via the 510(k) pathway on May 26, 2023. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Eclipse Treatment Planning System v18.0 is a software platform designed for planning radiation therapy treatments. It is used to optimize dose distribution for various cancer types, enhancing precision and efficacy in radiotherapy.
Clinical Applications
Common clinical scenarios for the Eclipse system include planning treatments for complex cancer cases such as bilateral breast cancer and cervical cancer. It is particularly useful in scenarios requiring precise dose calculations and optimization.
Evidence Summary
The available literature includes 7 studies, primarily from 2025, covering randomized controlled trials and retrospective analyses. These studies focus on dosimetric accuracy, planning quality, and automation in treatment planning.
Reported Outcomes
Published studies report improvements in dose calculation accuracy and planning efficiency, particularly with the use of enhanced leaf models and GPU-accelerated algorithms. The system shows promise in automating complex treatment plans, potentially reducing manual planning time.
Safety Profile
Reported complications include potential dose calculation errors due to algorithmic limitations, which may require plan re-optimization. However, no significant adverse events have been highlighted in the current evidence.
Evidence Limitations
The evidence is limited by the novelty of the enhanced leaf model and the need for further research on its real-world dosimetric sensitivity. More studies are required to validate the long-term clinical outcomes and safety of automated planning techniques.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System v18.0?
The system is indicated for use in planning radiation therapy for various cancers, including complex cases like bilateral breast cancer and cervical cancer.
What outcomes have been reported in clinical studies?
Studies report improved dose calculation accuracy and planning efficiency, with advancements in automation and algorithmic optimization.
What complications have been reported?
Safety data indicate potential dose calculation errors, necessitating plan re-optimization, but no major adverse events 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.