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FDA 510(k)

Halcyon, Ethos Radiotherapy System (5.0)

K-Number: K261856 · 2026-08-03

ApplicantVarian Medical Systems, Inc.
Decision Date2026-08-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Halcyon, Ethos Radiotherapy System (5.0) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K261856. 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 2026-08-03. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K261856.

When did Halcyon, Ethos Radiotherapy System (5.0) receive FDA 510(k) clearance?

Halcyon, Ethos Radiotherapy System (5.0) received FDA 510(k) clearance on 2026-08-03, under 510(k) number K261856.

Who is the listed applicant for Halcyon, Ethos Radiotherapy System (5.0)?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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