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