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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diabetic retinopathy detection device
510(k) Number K213037
Device Name IDx-DR v2.3
Applicant
Digital Diagnostics Inc.
2300 Oakdale Blvd
Coralville,  IA  52241
Applicant Contact Ashley Miller
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number886.1100
Classification Product Code
PIB  
Date Received09/21/2021
Decision Date 06/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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