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FDA 510(k)

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

K-Number: K210500 · 2021-06-11

ApplicantElekta Limited
Decision Date2021-06-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is a medical device manufactured by Elekta Limited. It received FDA 510(k) clearance on 2021-06-11 under approval number K210500. 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 Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is a medical device that received FDA 510(k) clearance on 2021-06-11. It is manufactured by Elekta Limited. The 510(k) number is K210500.

When was Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD approved by the FDA?

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD received FDA 510(k) clearance on 2021-06-11, under approval number K210500.

What company makes Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is manufactured by Elekta Limited.

What is the FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?

The FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is IYE.

Other Devices by Elekta Limited

K182076Elekta Unity K192482Elekta Unity K192242Synergy Platform, Synergy, Infinity, VersaHD

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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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