Eclipse Treatment Planning System (18.1)
Varian Medical SystemsThe Eclipse Treatment Planning System (version 18.1) is a software tool designed by Varian Medical Systems to assist clinicians in planning radiation therapy for patients with malignant or benign diseases. It uses medical imaging to create a virtual patient model to simulate and optimize radiation dose distributions for external beam and internal radiation treatments, ensuring effective tumor targeting while minimizing damage to healthy tissues. This system includes features for proton therapy and advanced optimization algorithms to enhance treatment quality and delivery efficiency.
Intended Use
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal radiation (brachytherapy) treatments.
Technology
Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. It utilizes medical imaging-derived virtual patient models to simulate, calculate, and optimize radiation dose distribution inside the body. The system plans treatments for external beam irradiation with photon, electron, and proton beams, as well as internal brachytherapy using clinically approved radioisotopes. New features include integrated proton therapy solutions (RapidScan), an improved dynamic optimization algorithm (RapidArc Dynamic), and supports multi-institution workflows.
Performance
Software verification and validation were conducted following FDA guidance, including unit, integration, and system level testing. New features were tested for comparability to predicate device using measurement comparisons (Gamma evaluation), clinical objectives, and workflow testing. Performance results met applicable specifications. No animal or clinical studies were included. The device complies with multiple recognized standards for safety, usability, cybersecurity, and radiotherapy equipment requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2024
4 months - 2
FDA Approval
12/11/2024
Other devices from Varian Medical Systems
- Gating Reflector Block2024 • 510K
- Vitesse (5.0)2024 • 510K
- Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)2024 • 510K
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