📊 Evidence-Based Reference
Eclipse Treatment Planning System
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiotherapy treatments. It is FDA 510(k) cleared and supported by 15 studies, focusing on dose calculation accuracy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050296 ↗
Decision Date ?
November 3, 2005
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Eclipse Treatment Planning System was cleared through the FDA 510(k) pathway on November 3, 2005. It is manufactured by Varian Medical Systems and is 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 the optimal dose distribution for photon and electron beams, ensuring precise targeting of tumors while sparing healthy tissue.
FDA-Cleared Indications
- Used for the planning of external-beam radiotherapy treatments.
- Calculates dose distributions for photon and electron radiation beams.
- Supports treatment planning for radiation therapy delivered with compatible clinical equipment.
Clinical Applications
- Planning photon-beam radiation treatments for patients with cancer.
- Planning electron-beam radiation treatments for appropriate superficial or localized tumors.
- Calculating and evaluating the intended radiation dose distribution before treatment delivery.
- Developing treatment plans that define target coverage and help limit radiation to surrounding normal tissue.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2022 and 2024. These studies evaluate the system's dosimetric accuracy and clinical effectiveness.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations for both photon and electron beams. It is effective in optimizing dose distribution in tumor and organ-at-risk regions, enhancing treatment precision.
Safety Profile
Reported complications include potential inaccuracies in dose calculation due to model uncertainties, such as those related to multi-leaf collimator configurations. However, no significant adverse events have been documented.
Evidence Limitations
Current evidence is limited by the variability in study designs and the need for more large-scale, prospective trials. Further research is needed to validate findings across diverse patient populations and treatment settings.
Practical Considerations
- This is a software treatment-planning system, not an implantable or patient-contact device; it has no physical device size or vessel compatibility requirements.
- Treatment plans should be reviewed and approved by qualified radiation oncology professionals before radiation is delivered.
- Safe and accurate use depends on validated software configuration, appropriate imaging data, dose-calculation settings, and compatibility with the radiation treatment equipment.
- The system is not an MRI device and should not be evaluated using implant-style MRI safety categories. MRI images may be used for planning only when the clinical workflow supports image registration, geometric accuracy, and artifact management.
- The system does not replace clinical judgment, treatment verification, quality assurance, or monitoring for radiation-treatment risks.
Frequently Asked Questions
What are the clinical indications for Eclipse treatment planning system?
The Eclipse system is indicated for use in planning radiotherapy treatments for various cancers, including brain tumors, where precise dose calculation is critical.
What outcomes have been reported in clinical studies?
Studies report that the Eclipse system achieves accurate dose calculations and effective dose distribution, improving treatment precision in radiotherapy.
What complications have been reported?
Safety data indicate potential dose calculation inaccuracies due to model uncertainties, 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.