AEYE Health

GUDID 00085003651022

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)

Aeye Health, Inc.

Retinal image analysis software
Primary Device ID00085003651022
NIH Device Record Key2cd00afd-2163-4398-9b21-7427ad64ccad
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEYE Health
Version Model NumberAEYE-DS
Company DUNS118503339
Company NameAeye Health, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com
Phone1 866 262 7343
Emailsupport@aeyehealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100085003651022 [Primary]
GS100850035651001 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIBDiabetic Retinopathy Detection Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-06
Device Publish Date2023-09-28

On-Brand Devices [AEYE Health]

00850035651018AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate
00850035651001AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophth
00085003651022AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophth

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