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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K212074
Device Name ClariCT.AI
ClariPi Inc.
3F, 70-15, Ihwajang-gil
Seoul,  KR 03088
Applicant Contact Hyun-Sook Park
ClariPi USA Inc.
1645 Park Creek Ct.
Rochester Hills,  MI  48309
Correspondent Contact Harry Park
Regulation Number892.2050
Classification Product Code
Date Received07/02/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No