Devices · AEYE Health, Inc.

AEYE-DS

AEYE Health, Inc. is listed for AEYE-DS (K221183). The FDA list gives November 10, 2022 as the date of the final decision. The lead panel is Ophthalmic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PIB as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221183

Official FDA database record

Date of final decision

November 10, 2022

Company on the FDA list

AEYE Health, Inc.

Lead panel

Ophthalmic

Primary product code

PIB

openFDA device name for the code

Diabetic Retinopathy Detection Device

Device class

2

Regulation number

886.1100

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary