DeviceClearance

Product code PIB— Ophthalmic

AEYE-DS

Classification name
Diabetic Retinopathy Detection Device
Device class
Class 2
Regulation
21 CFR 886.1100
Advisory panel
Ophthalmic
Total cleared
8
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PIB under 21 CFR 886.1100, via openFDA

Market context for product code PIB

FDA has cleared 8 devices under product code PIB between 2018 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PIB

Recent clearances under product code PIB

Data sourced from openFDA. This site is unofficial and independent of the FDA.