RetinAI Discovery
K-Number: K211715 · 2022-04-28
ApplicantRetinai Medical AG
Decision Date2022-04-28
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RetinAI Discovery is a medical device manufactured by Retinai Medical AG. It received FDA 510(k) clearance on 2022-04-28 under approval 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. It is manufactured by Retinai Medical AG. The 510(k) number is K211715.
When was RetinAI Discovery approved by the FDA?
RetinAI Discovery received FDA 510(k) clearance on 2022-04-28, under approval number K211715.
What company makes RetinAI Discovery?
RetinAI Discovery is manufactured by Retinai Medical AG.
What is the FDA product code for RetinAI Discovery?
The FDA product code for RetinAI Discovery is NFJ.
Related Devices (Code: NFJ)
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.