FDA.reportPublic FDA data

IDx-DR

Primary DI
00860005195619
Brand
IDx-DR
Company
Digital Diagnostics Inc.
Model
V2
Published
2021-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K203629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203629000IDx-DRDigital Diagnostics, Inc.2021-06-10PIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005195619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005195619008600051956198600051956190860005195619

GMDN Terms#

Term, Definition table
TermDefinition
Automated retinopathy analysis system application softwareAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028582271
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005195626IDx-DRv2.32022-06-27

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
00850035651018AEYE HealthAeye Health, Inc.PIB2023-07-16
00860005195626IDx-DRDigital Diagnostics Inc.PIB2022-06-27
00860000470001EyeArtEyenuk, Inc.PIB2020-11-09