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eclipse treatment planning system
Varian Medical Systems
Summary: The Eclipse treatment planning system by Varian Medical Systems is used for radiotherapy treatment planning. Key evidence highlights its accuracy in dose calculations, especially in complex scenarios involving metal elements.
FDA Clearance Information
Pathway
510K
Number
K152393 ↗
Decision Date
September 18, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse treatment planning system was cleared by the FDA via the 510(k) pathway on September 18, 2015. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Eclipse treatment planning system is a software platform designed for planning radiotherapy treatments. It calculates radiation doses for various cancer treatments, ensuring precise targeting of tumors while sparing healthy tissue.
Clinical Applications
Commonly used in planning radiotherapy for cancer patients, the Eclipse system is particularly valuable in scenarios requiring precise dose calculations, such as treatments involving metal implants or complex anatomical structures.
Evidence Summary
The literature includes 15 studies, ranging from 2022 to 2024, encompassing various study types such as RCTs and retrospective analyses. These studies evaluate the system's dosimetric accuracy and its application in clinical settings.
Reported Outcomes
Published studies report that the Eclipse treatment planning system provides accurate dose calculations, even in challenging scenarios like the presence of metal elements. It is effective in ensuring precise dose distribution in tumor and organs at risk.
Safety Profile
Reported complications include potential dose calculation errors near metal elements, which can affect treatment accuracy. However, methods to mitigate these errors, such as CT metal artefact reduction, have been assessed.
Evidence Limitations
Evidence gaps include the need for more extensive studies on long-term outcomes and the system's performance in diverse clinical settings. Further research is needed to optimize its use in complex treatment scenarios.
Frequently Asked Questions
What are the clinical indications for Eclipse treatment planning system?
The Eclipse system is indicated for planning radiotherapy treatments, particularly in scenarios requiring precise dose calculations, such as cancer treatments involving metal implants.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculations and effective dose distribution in tumor and organs at risk, even in complex scenarios involving metal elements.
What complications have been reported?
Safety data indicate potential dose calculation errors near metal elements, but these can be mitigated with CT metal artefact reduction methods.
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.