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eclipse treatment planning system
Varian Medical Systems
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiation therapy treatments. It is primarily used in radiotherapy for cancer patients. Key evidence highlights its accuracy in dose calculation and handling of metal artefacts.
FDA Clearance Information
Pathway
510K
Number
K073020 ↗
Decision Date
December 19, 2007
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System was cleared by the FDA through the 510(k) pathway on December 19, 2007. 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 is a software platform designed to assist clinicians in planning radiation therapy treatments. It calculates and optimizes radiation doses for cancer patients, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissue.
Clinical Applications
Commonly used in the planning of radiotherapy treatments for various cancers, the Eclipse system is particularly valuable in scenarios requiring precise dose calculations, such as brain cancer radiotherapy and treatments involving metal implants.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, published between 2022 and 2024. These studies evaluate the system's dosimetric accuracy and its performance in different clinical scenarios.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations, even in the presence of metal artefacts, and effectively compares to other dose calculation methods like the PRIMO Monte Carlo code. It is noted for its efficiency in periodic constancy checks and dose distribution accuracy.
Safety Profile
Reported complications include potential dose errors in areas affected by metal artefacts, which can degrade image quality and affect treatment planning. However, methods to reduce these artefacts have been assessed and implemented to mitigate risks.
Evidence Limitations
Some studies highlight the need for further research into the system's performance with different tissue heterogeneities and the impact of various CT metal artefact reduction methods. There is also a need for larger-scale studies to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The Eclipse system is indicated for planning radiation therapy treatments, particularly in cancer patients requiring precise dose calculations.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculations and effective handling of metal artefacts, with comparisons to other dose calculation methods showing favorable results.
What complications have been reported?
Safety data indicate potential dose errors due to metal artefacts, though reduction methods have been assessed to mitigate these issues.
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.