Ethos Radiotherapy System, Halcyon
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192377 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 Radiotherapy System, Halcyon is a Linear Accelerator, Medical designed for the delivery of stereotactic radiosurgery and precision radiotherapy. It integrates advanced imaging, adaptive planning, and real-time dose delivery to target lesions, tumors, or other pathological conditions with high precision across the body.
This system is used in radiology settings for treatment planning, management, and delivery of radiation therapy. Supplied as a reusable medical device, it includes software components for treatment management and planning, with MRI safety considerations noted in its specifications. Authorised under FDA 510K and MDR, it operates within regulatory frameworks for Class II devices (OpenFDA: IYE, 892.5050).
Frequently asked questions
What types of radiation therapy treatments can the Ethos Radiotherapy System deliver, and how does it differ from traditional linear accelerators?
The Ethos Radiotherapy System is designed specifically for stereotactic radiosurgery (SRS) and precision radiotherapy, including treatments for lesions, tumors, or pathological conditions across the entire body. Unlike traditional linear accelerators, it integrates advanced imaging, adaptive planning, and real-time dose delivery, allowing for highly precise targeting with reduced exposure to surrounding healthy tissue. This system is particularly suited for complex cases requiring dynamic adjustments during treatment.
Is the Ethos Radiotherapy System reusable, and if so, what maintenance or cleaning considerations should be taken into account?
Yes, the Ethos Radiotherapy System is supplied as a reusable medical device. As with all reusable equipment, it requires adherence to strict manufacturer-recommended cleaning, sterilization, and maintenance protocols to ensure safety, functionality, and compliance with regulatory standards. Proper handling and servicing are critical to maintaining performance and preventing contamination or damage.
Does the Ethos Radiotherapy System include software components, and if so, what are their primary functions?
Yes, the system includes software components for Ethos Treatment Management and Ethos Treatment Planning, which enable clinicians to design, optimize, and deliver radiation therapy with precision. These tools facilitate adaptive planning, real-time dose adjustments, and integration with imaging systems to enhance treatment accuracy and efficiency. The software is an integral part of the system’s functionality, ensuring tailored and dynamic treatment delivery.
Are there any specific MRI safety considerations when using the Ethos Radiotherapy System, and why?
Yes, the Ethos Radiotherapy System includes MRI safety specifications in its design. This is because the system may be used in environments where MRI compatibility is a concern, such as when treating patients who require follow-up imaging or when the device itself must adhere to electromagnetic interference (EMI) guidelines. These considerations help ensure patient safety and avoid interference with diagnostic procedures.
What regulatory pathways does the Ethos Radiotherapy System follow, and how does this affect its use in clinical settings?
The Ethos Radiotherapy System is authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), classifying it as a Class II device in the U.S. This means it undergoes rigorous review by regulatory bodies to ensure safety and effectiveness before clinical use. Clinicians can rely on its compliance with these frameworks, which include adherence to manufacturing, performance, and labeling standards, ensuring consistent and high-quality treatment delivery.
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. Sources consulted: Ethos Treatment Management, Ethos Treatment Planning, Ethos ..., Ethos | Siemens Healthineers | Cancer Care - Varian, PDF Ethos therapy Feature Sheet E - irocmed.com
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 | K192377 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K192377 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026