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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K203785
Device Name ClariSIGMAM
ClariPi Inc.
3F, 70-15, Ihwajang-gil
Seoul,  KR 03088
Applicant Contact Hyun-Sook Park
ClariPi Detroit Office
1645 Park Creek Ct. Rochester Hills
Detroit,  MI  48309
Correspondent Contact Harry Park
Regulation Number892.2050
Classification Product Code
Date Received12/28/2020
Decision Date 09/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No