FDA 510(k)

Exo Iris (El2001)

K-Number: K222198 · 2022-11-09

Decision Date2022-11-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Exo Iris (El2001) is the device name listed in this FDA 510(k) record. The listed applicant is Exo Imaging, Inc.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) 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. The listed applicant is Exo Imaging, Inc.. The 510(k) number is K222198.

When did Exo Iris (El2001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Exo Iris (El2001)?

The FDA 510(k) record lists Exo Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Exo Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260217AI Platform 2.2 (AIP002)K240953AI Platform 2.0 (AIP002)K211527Exo Iris

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Official Source

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