FDA 510(k)

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

K-Number: K192377 · 2020-02-10

Decision Date2020-02-10

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon 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 2020-02-10 under 510(k) number K192377. 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 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon?

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K192377.

When did Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon receive FDA 510(k) clearance?

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon received FDA 510(k) clearance on 2020-02-10, under 510(k) number K192377.

Who is the listed applicant for Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon?

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 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon?

The FDA product code for Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon is IYE.

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Related Devices (Code: 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.