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 Eyenuk, Inc., Digital Diagnostics, Inc. and Aeye Health, Inc..
8
Total
7
Cleared
179d
Avg days
2018
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
220d
recently vs 173d historically
FDA 510(k) Cleared Diabetic Retinopathy Detection Device Devices (Product Code PIB)
8 devices
Cleared
Apr 23, 2024
AEYE-DS
Aeye Health, Inc.
Ophthalmic
106d
Cleared
Jun 16, 2023
EyeArt v2.2.0
Eyenuk, Inc.
Ophthalmic
226d
Cleared
Nov 10, 2022
AEYE-DS
Aeye Health, Inc.
Ophthalmic
199d
Cleared
Jun 17, 2022
IDx-DR v2.3
Digital Diagnostics, Inc.
Ophthalmic
269d
Cleared
Jun 10, 2021
IDx-DR
Digital Diagnostics, Inc.
Ophthalmic
181d
Cleared
Aug 03, 2020
EyeArt
Eyenuk, Inc.
Ophthalmic
143d
Not Cleared
Apr 11, 2018
IDx-DR
Idx, LLC
Ophthalmic
89d
About Product Code PIB - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PIB since 2018, with 7 receiving FDA clearance (average review time: 179 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - PIB Product Code
Recent submissions under PIB have taken an average of 220 days to reach a decision - up from 173 days historically. Manufacturers should account for longer review timelines in current project planning.
PIB devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →