Halcyon Ethos Radiotherapy System (5.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252977 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 Halcyon Ethos Radiotherapy System (5.0) is a Medical Linear Accelerator (Linac) designed for Image-Guided Radiation Therapy (IGRT) and stereotactic radiosurgery. It delivers precise radiation treatment for lesions, tumors, and other conditions throughout the body, integrating advanced imaging and adaptive radiotherapy capabilities to enhance accuracy and patient outcomes.
This system is intended for use in radiation oncology departments and is supplied as a single-use or reusable (where applicable) medical device, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. It operates within standard clinical environments and adheres to Class II (Radiology) medical device classification, with no specific MRI safety restrictions noted. The system is available in a standardized configuration, supported by Varian’s regulatory submissions (K252977, IYE product code) and intended for professional medical use only.
Frequently asked questions
What types of radiation treatments can the Halcyon Ethos Radiotherapy System (5.0) deliver, and how does it improve accuracy compared to traditional methods?
The Halcyon Ethos Radiotherapy System (5.0) is designed for Image-Guided Radiation Therapy (IGRT) and stereotactic radiosurgery, enabling precise delivery of radiation to lesions, tumors, or other targeted areas throughout the body. Its advanced imaging and adaptive radiotherapy capabilities enhance accuracy by integrating real-time imaging during treatment, reducing errors from patient movement or anatomical changes. This ensures higher precision compared to traditional linear accelerators, improving outcomes for complex cases.
Is the Halcyon Ethos Radiotherapy System (5.0) compatible with MRI environments, and what safety considerations should be noted?
The Halcyon Ethos Radiotherapy System (5.0) does not have specific MRI safety restrictions mentioned in its documentation, meaning it is not designed for use inside an MRI scanner. However, it is intended for standard clinical radiation oncology environments. Clinicians should follow standard electromagnetic interference (EMI) protocols when operating near MRI-compatible equipment, though the system itself is not MRI-compatible.
How is the Halcyon Ethos Radiotherapy System (5.0) supplied, and are there any reusable components that require special handling?
The Halcyon Ethos Radiotherapy System (5.0) is supplied as a standardized medical device configuration, with some components designed for single-use and others for reuse where applicable. Reusable parts must undergo proper cleaning, sterilization, and maintenance per manufacturer guidelines to ensure safety and performance. The system’s design prioritizes clinical workflow efficiency while adhering to regulatory standards for reusable medical devices.
What regulatory pathways does the Halcyon Ethos Radiotherapy System (5.0) follow, and how does this affect its adoption in different markets?
The Halcyon Ethos Radiotherapy System (5.0) holds FDA 510(k) clearance and MDR compliance, meaning it has undergone regulatory review in the U.S. and EU markets. The FDA clearance is based on a substantially equivalent determination under the Radiology (RA) advisory committee, while MDR compliance ensures adherence to European medical device regulations. These pathways validate its safety and effectiveness for professional medical use in radiation oncology, facilitating adoption in both markets.
Are there multiple configurations or models available for the Halcyon Ethos Radiotherapy System (5.0), or is it supplied as a single standardized unit?
The Halcyon Ethos Radiotherapy System (5.0) is supplied in a standardized configuration, meaning it is not offered in multiple physical models or customizable setups. However, its advanced imaging and adaptive radiotherapy features provide flexibility for various clinical applications, including IGRT and stereotactic radiosurgery. The system’s unified design ensures consistency in performance and regulatory compliance across installations.
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: Halcyon, Ethos Radiotherapy System (5.0) (K252977) — FDA 510 (k ..., Halcyon, Ethos Radiotherapy System (5.0) (K261856) — FDA 510 (k ..., Halcyon Dive Systems - Precision-crafted dive gear for explorers, K252977 FDA 510(k) - Halcyon | Varian Medical Systems, Inc.
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 | K252977 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K252977 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026