FDA 510(k)

Synergy Platform, Synergy, Infinity, VersaHD

K-Number: K192242 · 2019-11-22

Decision Date2019-11-22

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Synergy Platform, Synergy, Infinity, VersaHD is a medical device manufactured by Elekta Limited. It received FDA 510(k) clearance on 2019-11-22 under approval number K192242. 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 Synergy Platform, Synergy, Infinity, VersaHD?

Synergy Platform, Synergy, Infinity, VersaHD is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Elekta Limited. The 510(k) number is K192242.

When was Synergy Platform, Synergy, Infinity, VersaHD approved by the FDA?

Synergy Platform, Synergy, Infinity, VersaHD received FDA 510(k) clearance on 2019-11-22, under approval number K192242.

What company makes Synergy Platform, Synergy, Infinity, VersaHD?

Synergy Platform, Synergy, Infinity, VersaHD is manufactured by Elekta Limited.

What is the FDA product code for Synergy Platform, Synergy, Infinity, VersaHD?

The FDA product code for Synergy Platform, Synergy, Infinity, VersaHD is IYE.

Other Devices by Elekta Limited

K182076Elekta Unity K192482Elekta Unity 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.