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FDA 510(k)

Halcyon, Ethos Radiotherapy System (5.0)

K-Number: K252977 · 2026-01-21

ApplicantVarian Medical Systems, Inc.
Decision Date2026-01-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Halcyon, Ethos Radiotherapy System (5.0) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-21 under approval number K252977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halcyon, Ethos Radiotherapy System (5.0)?

Halcyon, Ethos Radiotherapy System (5.0) is a medical device that received FDA 510(k) clearance on 2026-01-21. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K252977.

When was Halcyon, Ethos Radiotherapy System (5.0) approved by the FDA?

Halcyon, Ethos Radiotherapy System (5.0) received FDA 510(k) clearance on 2026-01-21, under approval number K252977.

What company makes Halcyon, Ethos Radiotherapy System (5.0)?

Halcyon, Ethos Radiotherapy System (5.0) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Halcyon, Ethos Radiotherapy System (5.0)?

The FDA product code for Halcyon, Ethos Radiotherapy System (5.0) is IYE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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