PIBClass II

Diabetic Retinopathy Detection Device

Ophthalmic · 21 CFR 886.1100

A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.

MDR events1All time

Recalls0All time

Registered firms7Currently listed

510(k) clearances8All time

Recent MDR events

1 adverse event reports on file

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AEYE-DS RETINA SCREENINGJan 22, 2025
InjuryAeye Health Inc.MW5165159

Event type breakdown

Injury1

Most-reported manufacturers

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Aeye Health Inc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

7 firms currently registered for this product code

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Digital Diagnostics Inc.
Coralville, IA, US
Aeye Health Inc.
New York, NY, US
Eyenuk
Woodland Hills, CA, US

510(k) clearances

8 clearances for this product code

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iHealthscreen, Inc.Jul 2, 2026
K253704 · iPredict-DR
Aeye Health, Inc.Apr 23, 2024
K240058 · AEYE-DS
Eyenuk, Inc.Jun 16, 2023
K223357 · EyeArt v2.2.0
Aeye Health, Inc.Nov 10, 2022
K221183 · AEYE-DS
Digital Diagnostics, Inc.Jun 17, 2022
K213037 · IDx-DR v2.3
Digital Diagnostics, Inc.Jun 10, 2021
K203629 · IDx-DR
Eyenuk, Inc.Aug 3, 2020
K200667 · EyeArt
Idx, LLCApr 11, 2018
DEN180001 · IDx-DR