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FDA 510(k)

Exo Iris (El2001)

K-Number: K222198 · 2022-11-09

ApplicantExo Imaging, Inc.
Decision Date2022-11-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Exo Iris (El2001) is a medical device manufactured by Exo Imaging, Inc.. It received FDA 510(k) clearance on 2022-11-09 under approval number K222198. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exo Iris (El2001)?

Exo Iris (El2001) is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Exo Imaging, Inc.. The 510(k) number is K222198.

When was Exo Iris (El2001) approved by the FDA?

Exo Iris (El2001) received FDA 510(k) clearance on 2022-11-09, under approval number K222198.

What company makes Exo Iris (El2001)?

Exo Iris (El2001) is manufactured by Exo Imaging, Inc..

What is the FDA product code for Exo Iris (El2001)?

The FDA product code for Exo Iris (El2001) is IYN.

Other Devices by Exo Imaging, Inc.

K211527Exo Iris

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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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