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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
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