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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 K183460
Device Name ClariCT.AI
Applicant
ClariPI Inc.
3F, 70-15, Ihwajang-gil
Seoul,  KR 03088
Applicant Contact Hyun-Sook Park
Correspondent
OTech Inc
8317 Belew Drive
McKinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/13/2018
Decision Date 06/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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