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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 K253704
Device Name iPredict-DR
Applicant
iHealthscreen, Inc.
132-02 89th Ave., Suite 214
Richmond Hill,  NY  11418
Applicant Contact Alauddin Bhuiyan
Correspondent
iHealthscreen, Inc.
132-02 89th Ave., Suite 214
Richmond Hill,  NY  11418
Correspondent Contact Alauddin Bhuiyan
Regulation Number886.1100
Classification Product Code
PIB  
Date Received11/24/2025
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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