Halcyon, Ethos Radiotherapy System (5.0)
FDA 510(k) K252977 · Varian Medical Systems, Inc.
510(k) numberK252977
Submission
- Device name
- Halcyon, Ethos Radiotherapy System (5.0)
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- September 17, 2025
- Decision date
- January 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252919 | Identify (5.0)IYE · Traditional | 12/16/2025SE |
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Questions and answers
When was Halcyon, Ethos Radiotherapy System (5.0) cleared by the FDA?
Halcyon, Ethos Radiotherapy System (5.0) (K252977) received a 510(k) decision of Substantially Equivalent on January 21, 2026, 126 days after the submission was received.
What is the product code of K252977?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.