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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 K220039
Device Name AutoSeg
Applicant
Ai Medic, Inc.
2f, 437, Bongeunsa-Ro, Gangnam-Gu
Seoul,  KR KS013/06097
Applicant Contact Jeong Soon Song
Correspondent
Ai Medic, Inc.
2f, 437, Bongeunsa-Ro, Gangnam-Gu
Seoul,  KR KS013/06097
Correspondent Contact Jeong Soon Song
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/05/2022
Decision Date 07/20/2022
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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