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Eclipse Treatment Planning System
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiotherapy treatments. It is primarily used to calculate and optimize radiation doses for cancer patients. Key evidence highlights its effectiveness in dose calculation and comparison with other systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141283 ↗
Decision Date ?
August 7, 2014
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 August 7, 2014. 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 to assist clinicians in planning radiation therapy treatments. It calculates and optimizes radiation doses for various cancer types, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissues.
FDA-Cleared Indications
- For use by qualified professionals to plan radiation therapy treatments.
- For calculation and evaluation of radiation dose distributions used in radiotherapy treatment planning.
- For use in conjunction with compatible radiation therapy delivery systems.
Clinical Applications
- Planning external-beam radiation therapy for patients with cancer.
- Calculating radiation dose distributions before treatment delivery.
- Comparing and optimizing treatment plans to support target coverage and reduce dose to nearby normal tissues.
- Preparing treatment plans for delivery with compatible linear accelerator systems.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as retrospective analyses and technical reports. These studies span from 2022 to 2024, focusing on the system's dosimetric accuracy and comparison with other planning systems.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations for both photon and electron therapies. It has been shown to effectively compare with the PRIMO Monte Carlo code in brain cancer radiotherapy, ensuring reliable dose distribution in tumors and organs at risk.
Safety Profile
Reported complications include potential inaccuracies in dose calculations due to uncertainties in multi-leaf collimator modeling. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials. Most studies are technical reports or retrospective analyses, which may not fully capture the clinical impact of the system. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The system is software rather than an implantable or disposable device and does not have a physical patient size range.
- Compatibility with treatment machines, imaging systems, dose-calculation algorithms, and oncology information systems must be verified before clinical use.
- Treatment plans require review and approval by qualified radiation oncology professionals before radiation is delivered.
- The system is not an MRI device and is not classified as MRI safe, MRI conditional, or MRI unsafe; MRI images may be used for planning only when acquired and handled according to the applicable imaging and software workflows.
- The software does not deliver radiation itself; treatment delivery depends on a separately cleared radiation therapy system.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The Eclipse system is indicated for planning radiation therapy treatments in various cancers, including brain cancer, where precise dose calculations are critical.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and effective comparison with other systems, ensuring reliable treatment planning for cancer patients.
What complications have been reported?
Safety data indicate potential inaccuracies in dose calculations due to modeling 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.