FDA 510(k)

RetinAI Discovery

K-Number: K211715 · 2022-04-28

Decision Date2022-04-28

Product CodeNFJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RetinAI Discovery is the device name listed in this FDA 510(k) record. The listed applicant is Retinai Medical AG. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K211715. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RetinAI Discovery?

RetinAI Discovery is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Retinai Medical AG. The 510(k) number is K211715.

When did RetinAI Discovery receive FDA 510(k) clearance?

RetinAI Discovery received FDA 510(k) clearance on 2022-04-28, under 510(k) number K211715.

Who is the listed applicant for RetinAI Discovery?

The FDA 510(k) record lists Retinai Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RetinAI Discovery?

The FDA product code for RetinAI Discovery is NFJ.

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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.