Ethos Treatment Management, Ethos Treatment Planning
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212294 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ethos Treatment Management and Treatment Planning is a Radiation Therapy Planning System and Treatment Management System designed for linear accelerators. It integrates advanced imaging, treatment planning, and delivery management to optimize radiation therapy for cancer patients, ensuring precise dose distribution and adaptive treatment strategies based on real-time patient data.
This system is supplied as a software solution for use in radiation oncology departments, interfacing with linear accelerators and imaging modalities. It is intended for single-use or multi-user environments, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. The device operates in non-MRI environments and requires appropriate storage conditions as specified by the manufacturer. Authorizations include K212294 under the FDA’s Special 510(k) review pathway, with classification as a Class II medical device under 21 CFR 892.5050.
Frequently asked questions
What is the primary purpose of the Ethos Treatment Management and Treatment Planning system in a clinical setting?
The Ethos system is designed to optimize radiation therapy for cancer patients by integrating advanced imaging, treatment planning, and delivery management. It ensures precise dose distribution and adaptive treatment strategies based on real-time patient data, improving the accuracy and effectiveness of radiation therapy delivered via linear accelerators.
How is the Ethos system supplied, and is it intended for single-use or multi-user environments?
The Ethos system is supplied as a software solution for radiation oncology departments, interfacing with linear accelerators and imaging modalities. It is explicitly intended for use in both single-use and multi-user environments, depending on the clinical workflow and departmental setup.
What regulatory pathways has the Ethos system undergone, and what does this mean for its use in clinical practice?
The Ethos system holds FDA 510(k) clearance under the Special 510(k) review pathway (K212294) and is compliant with the EU Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness by regulatory authorities, ensuring it meets established standards for radiation therapy planning and management systems in approved clinical settings.
Does the Ethos system require any specific storage conditions, and where is it typically used?
The Ethos system operates in non-MRI environments and must be stored according to the manufacturer’s guidelines, which likely include environmental factors like temperature and humidity. It is designed for use in radiation oncology departments where linear accelerators and imaging modalities are present.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212294 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K212294 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026