FDA 510(k)

Halcyon

K-Number: K170817 · 2017-06-27

Decision Date2017-06-27

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Halcyon is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-06-27 under approval number K170817. 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?

Halcyon is a medical device that received FDA 510(k) clearance on 2017-06-27. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K170817.

When was Halcyon approved by the FDA?

Halcyon received FDA 510(k) clearance on 2017-06-27, under approval number K170817.

What company makes Halcyon?

Halcyon is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Halcyon?

The FDA product code for 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.