RetinAI Discovery— 510(k) K211715

Substantially Equivalent

Retinai Medical AG

FDA 510(k) clearance K211715 for RetinAI Discovery, Substantially Equivalent on 2022-04-28. Applicant: Retinai Medical AG.

Clearance details

Applicant: Retinai Medical AG
Product code: Code NFJ
Advisory panel: Radiology
Date received: 2021-06-03
Decision date: 2022-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bern, CH

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