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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
ClariPI Inc.
3F, 70-15, Ihwajang-gil
seoul,  KR 03088
Applicant Contact hyun-sook park
OTech Inc
8317 Belew Drive
mckinney,  TX  75071
Correspondent Contact carl alletto
Regulation Number892.2050
Classification Product Code
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