PIB

Diabetic Retinopathy Detection Device

Product code: PIB
Device name: Diabetic Retinopathy Detection Device
Device class: Class 2
21 CFR: 21 CFR 886.1100
Medical specialty: Ophthalmic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 2
Summaries archived here: 2 (direct download)
510(k) clearances (all years, FDA): 8 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-07-02.

Number	Decision date	Applicant	Device name	Summary
K253704	2026-07-02	iHealthscreen, Inc.	iPredict-DR	PDF
K240058	2024-04-23	Aeye Health, Inc.	AEYE-DS	PDF

2 summaries are archived here for direct download.

Official FDA classification page: PIB

Classification and pathway per current FDA publications. Data from openFDA (CC0).