FDA 510(k)

Exo Iris

K-Number: K211527 · 2021-08-20

Decision Date2021-08-20

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Exo Iris 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 2021-08-20 under 510(k) number K211527. 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?

Exo Iris is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Exo Imaging, Inc.. The 510(k) number is K211527.

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

Exo Iris received FDA 510(k) clearance on 2021-08-20, under 510(k) number K211527.

Who is the listed applicant for Exo Iris?

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?

The FDA product code for Exo Iris 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)K222198Exo Iris (El2001)

Related Devices (Code: IYN)

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.