Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, and Halcyon are integrated tools designed to help clinicians manage, plan, and deliver radiation therapy treatment. The software supports radiation therapy plan management and adaptive treatment planning, while the radiotherapy systems deliver precise radiation treatment using image guidance to treat lesions and tumors anywhere in the body. These tools aim to improve the accuracy and effectiveness of radiotherapy for patients, including adults and pediatric patients.
Intended Use
Ethos Treatment Management is used to manage and monitor radiation therapy treatment plans and sessions; Ethos Treatment Planning is used to generate and modify radiation therapy treatment plans; Ethos Radiotherapy System and Halcyon provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body for adults and pediatric patients.
Technology
The system includes stand-alone software for radiation therapy management and planning, and medical linear accelerators designed to deliver image-guided radiotherapy using Intensity Modulated and Volumetric Modulated Arc Therapy. It features tools for adaptive radiotherapy planning and delivery, motion monitoring, patient support, and integrated imaging components such as kV imagers and patient cameras.
Performance
Verification and validation testing including software testing, hardware safety, and electromagnetic compatibility were conducted demonstrating conformance to applicable standards. Testing showed the devices meet performance requirements and maintain safety and effectiveness. No clinical or animal studies were included in this submission, with software considered to have a major level of concern due to potential patient impact of failure.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/30/2019
5 months - 2
FDA Approval
2/10/2020
Other devices from Varian Medical Systems, Inc.
- 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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