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eclipse treatment planning system v16 1
Varian Medical Systems
Summary: The Eclipse Treatment Planning System v16 1 by Varian Medical Systems is a radiation therapy planning device. It is primarily used for optimizing radiation dose delivery in cancer treatment. Key evidence highlights its role in improving dosimetric accuracy and treatment efficiency.
FDA Clearance Information
Pathway
510K
Number
K201607 ↗
Decision Date
July 10, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Treatment Planning System v16 1 was cleared by the FDA via the 510(k) pathway on July 10, 2020. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Eclipse Treatment Planning System v16 1 is a software platform used in radiation therapy to plan and optimize the delivery of radiation doses to cancerous tissues while minimizing exposure to surrounding healthy tissues. It is designed for use by clinicians in various oncological settings.
Clinical Applications
This device is commonly used in clinical scenarios involving complex radiation therapy planning, such as stereotactic radiosurgery and stereotactic body radiotherapy. It aids in creating precise treatment plans that account for patient-specific anatomical and physiological characteristics.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2025 and 2026. These studies evaluate the system's dosimetric capabilities and planning efficiency.
Reported Outcomes
Published studies report that the Eclipse Treatment Planning System v16 1 enhances dosimetric accuracy and treatment efficiency in radiation therapy. It has been shown to improve target coverage while sparing organs at risk, particularly in complex cases such as unilateral radiotherapy for tonsillar cancer and lung SBRT.
Safety Profile
Reported complications include potential discrepancies in dose calculations due to variations in tissue density and elemental composition, as highlighted in studies evaluating CT number accuracy. However, no significant adverse events directly related to the device's use were noted.
Evidence Limitations
The evidence highlights gaps in established planning guidelines for certain treatment modalities, such as unilateral radiotherapy. Further research is needed to refine dosimetric models and validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System v16 1?
The device is indicated for use in planning radiation therapy treatments for various cancers, optimizing dose delivery while minimizing exposure to healthy tissues.
What outcomes have been reported in clinical studies?
Studies report improved dosimetric accuracy and treatment efficiency, with enhanced target coverage and sparing of organs at risk in complex radiation therapy scenarios.
What complications have been reported?
Safety data indicate potential dose calculation discrepancies due to CT number variations, but no significant adverse events directly related to the device 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.