AEYE Health

Primary DI: 00850035651001
Brand: AEYE Health
Company: Aeye Health, Inc.
Model: AEYE-DS
Device description: AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Published: 2023-07-16
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Contact Domains#

Code, Name table
Code	Name
PIB	Diabetic Retinopathy Detection Device

Code, Device, Specialty table
Code	Device	Specialty	Class
PIB	Diabetic Retinopathy Detection Device	Ophthalmic	2

Submission, Supplement table
Submission	Supplement
K221183	000
K240058	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K221183	000	AEYE-DS	Aeye Health, Inc.	2022-11-10	PIB
K240058	000	AEYE-DS	Aeye Health, Inc.	2024-04-23	PIB

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00850035651001	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00850035651001	00850035651001	850035651001	0850035651001

Term, Definition table
Term	Definition
Ophthalmic image clinical assessment support software, professional-only	A software program intended to be used in a clinical setting to display and analyse/process images of the eye, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of an ophthalmic condition. The images are typically acquired by a slit lamp, fundus camera, or via optical coherence tomography. The software is not dedicated to surgical planning or intraoperative use, and does not incorporate adaptive/dynamic machine learning (ML) models.

Phone, Email table
Phone	Email
1 866 262 7343	support@aeyehealth.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
00850035651032	AEYE Health	AEYE-DS	2025-02-10
00085003651039	AEYE Health	AEYE-DS	2024-12-12
00085003651022	AEYE Health	AEYE-DS	2023-09-28
00850035651018	AEYE Health	AEYE-DS-Epic	2023-07-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00850035651032	AEYE Health	Aeye Health, Inc.	PIB	2025-02-10
00085003651039	AEYE Health	Aeye Health, Inc.	PIB	2024-12-12
00085003651022	AEYE Health	Aeye Health, Inc.	PIB	2023-09-28
00850035651018	AEYE Health	Aeye Health, Inc.	PIB	2023-07-16
00860005195626	IDx-DR	Digital Diagnostics Inc.	PIB	2022-06-27
00860005195619	IDx-DR	Digital Diagnostics Inc.	PIB	2021-07-09
00860000470001	EyeArt	Eyenuk, Inc.	PIB	2020-11-09