FDA 510(k)

Varian Head Frame

K-Number: K180586 · 2018-04-02

Decision Date2018-04-02

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Varian Head Frame is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-04-02 under approval number K180586. 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 Varian Head Frame?

Varian Head Frame is a medical device that received FDA 510(k) clearance on 2018-04-02. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K180586.

When was Varian Head Frame approved by the FDA?

Varian Head Frame received FDA 510(k) clearance on 2018-04-02, under approval number K180586.

What company makes Varian Head Frame?

Varian Head Frame is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Varian Head Frame?

The FDA product code for Varian Head Frame is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.