PIB · Class II · 21 CFR 886.1100

FDA Product Code PIB: Diabetic Retinopathy Detection Device

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.

Leading manufacturers include Digital Diagnostics, Inc., Aeye Health, Inc. and Eyenuk, Inc..

7
Total
6
Cleared
173d
Avg days
2018
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Diabetic Retinopathy Detection Device Devices (Product Code PIB)

7 devices
1–7 of 7
Cleared Apr 23, 2024
AEYE-DS
K240058
Aeye Health, Inc.
Ophthalmic · 106d
Cleared Jun 16, 2023
EyeArt v2.2.0
K223357
Eyenuk, Inc.
Ophthalmic · 226d
Cleared Nov 10, 2022
AEYE-DS
K221183
Aeye Health, Inc.
Ophthalmic · 199d
Cleared Jun 17, 2022
IDx-DR v2.3
K213037
Digital Diagnostics, Inc.
Ophthalmic · 269d
Cleared Jun 10, 2021
IDx-DR
K203629
Digital Diagnostics, Inc.
Ophthalmic · 181d

About Product Code PIB - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code PIB since 2018, with 6 receiving FDA clearance (average review time: 173 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.

PIB devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →