FDA 510(k)

Elekta Unity

K-Number: K182076 · 2018-12-04

Decision Date2018-12-04

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Elekta Unity is a medical device manufactured by Elekta Limited. It received FDA 510(k) clearance on 2018-12-04 under approval number K182076. 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 Elekta Unity?

Elekta Unity is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Elekta Limited. The 510(k) number is K182076.

When was Elekta Unity approved by the FDA?

Elekta Unity received FDA 510(k) clearance on 2018-12-04, under approval number K182076.

What company makes Elekta Unity?

Elekta Unity is manufactured by Elekta Limited.

What is the FDA product code for Elekta Unity?

The FDA product code for Elekta Unity is IYE.

Other Devices by Elekta Limited

K192482Elekta Unity K192242Synergy Platform, Synergy, Infinity, VersaHD K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

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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.