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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 K203629
Device Name IDx-DR
Applicant
Digital Diagnostics, Inc.
2300 Oakdale Blvd.
Coralville,  IA  52241
Applicant Contact Ashley Miller
Correspondent
Digital Diagnostics, Inc.
2300 Oakdale Blvd.
Coralville,  IA  52241
Correspondent Contact Ashley Miller
Regulation Number886.1100
Classification Product Code
PIB  
Date Received12/11/2020
Decision Date 06/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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