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FDA 510(k)

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

K-Number: K192377 · 2020-02-10

ApplicantVarian Medical Systems, Inc.
Decision Date2020-02-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

When was Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon approved by the FDA?

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

What company makes Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon?

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon is manufactured by Varian Medical Systems, Inc..

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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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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