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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 in radiotherapy planning. It is primarily used for calculating dosimetric parameters in cancer treatment. Key evidence highlights its efficiency in dose calculation and comparison with other systems.
FDA Clearance Information
Pathway
510K
Number
K181145 ↗
Decision Date
May 18, 2018
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 May 18, 2018. It is manufactured by Varian Medical Systems and is classified as a Class 2 medical device.
What It Is
The Eclipse Treatment Planning System is a software platform used in radiotherapy to plan and calculate the optimal dose distribution for cancer treatment. It is designed to assist clinicians in developing precise treatment plans by simulating radiation dose delivery.
Clinical Applications
Commonly used in planning radiotherapy for various cancers, the Eclipse system helps in calculating dose distributions for tumor and organs at risk. It is particularly useful in complex treatments like volumetric modulated arc therapy (VMAT).
Evidence Summary
The available literature includes 15 studies, comprising various study types such as retrospective and prospective analyses. These studies span from 2022 to 2024, focusing on the system's dosimetric accuracy and efficiency.
Reported Outcomes
Published studies report that the Eclipse Treatment Planning System provides accurate dose calculations for both photon and electron beams. It has been shown to effectively compare with other systems like the PRIMO Monte Carlo code in brain cancer radiotherapy. The system's ability to model complex scenarios, such as dual-layer multi-leaf collimators, is also highlighted.
Safety Profile
Reported complications include potential discrepancies in dose calculations due to variations in multi-leaf collimator models. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The system is indicated for use in planning radiotherapy treatments, particularly in calculating dose distributions for cancer therapy.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculations and effective comparisons with other systems, particularly in complex treatment scenarios.
What complications have been reported?
Safety data indicate potential discrepancies in dose calculations due to model variations, but no significant 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.