FDA.reportPublic FDA data

AEYE Health

Primary DI
00850035651018
Brand
AEYE Health
Company
Aeye Health, Inc.
Model
AEYE-DS-Epic
Device description
AEYE-DS-Epic 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-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
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

Product Codes#

Code, Name table
CodeName
PIBDiabetic Retinopathy Detection Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIBDiabetic Retinopathy Detection DeviceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221183000
K240058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221183000AEYE-DSAeye Health, Inc.2022-11-10PIB
K240058000AEYE-DSAeye Health, Inc.2024-04-23PIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035651018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035651018008500356510188500356510180850035651018

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic image clinical assessment support software, professional-onlyA 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.

Regulatory Flags#

DUNS number
118503339
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035651032AEYE HealthAEYE-DS2025-02-10
00085003651039AEYE HealthAEYE-DS2024-12-12
00085003651022AEYE HealthAEYE-DS2023-09-28
00850035651001AEYE HealthAEYE-DS2023-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850035651032AEYE HealthAeye Health, Inc.PIB2025-02-10
00085003651039AEYE HealthAeye Health, Inc.PIB2024-12-12
00085003651022AEYE HealthAeye Health, Inc.PIB2023-09-28
00850035651001AEYE HealthAeye Health, Inc.PIB2023-07-16
00860005195626IDx-DRDigital Diagnostics Inc.PIB2022-06-27
00860005195619IDx-DRDigital Diagnostics Inc.PIB2021-07-09
00860000470001EyeArtEyenuk, Inc.PIB2020-11-09