FDA 510(k)

Halcyon, Ethos Radiotherapy System (5.0)

Número K: K252977 · 2026-01-21

Data da decisão2026-01-21

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2026-01-21 under 510(k) number K252977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252977.

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 2026-01-21, under 510(k) number K252977.

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)?

O código de produto FDA para o sistema de radioterapia Halcyon, Ethos (5.0) é IYE.

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Fonte oficial

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