IDx-DR V2.3

Diabetic Retinopathy Detection Device

Digital Diagnostics Inc.

The following data is part of a premarket notification filed by Digital Diagnostics Inc. with the FDA for Idx-dr V2.3.

Pre-market Notification Details

Device IDK213037
510k NumberK213037
Device Name:IDx-DR V2.3
ClassificationDiabetic Retinopathy Detection Device
Applicant Digital Diagnostics Inc. 2300 Oakdale Blvd Coralville,  IA  52241
ContactAshley Miller
CorrespondentKelliann Payne
Hogan Lovells US LLP 1735 Market St., Floor 23 Philadelphia,  PA  19103
Product CodePIB  
CFR Regulation Number886.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-21
Decision Date2022-06-17

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