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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
Applicant
Claripi, Inc.
3f, 70-15, Ihwajang-Gil
Seoul,  KR 03088
Applicant Contact Hyun-Sook Park
Correspondent
Claripi USA, Inc.
1645 Park Creek Ct.
Rochester Hills,  MI  48309
Correspondent Contact Harry Park
Regulation Number892.2050
Classification Product Code
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
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