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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 K193220
Device Name AVIEW LCS
Applicant
Coreline Soft Co., Ltd
4, 5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu
Seoul,  KR 03991
Applicant Contact Hyeyi Park
Correspondent
Coreline Soft Co., Ltd
4, 5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu
Seoul,  KR 03991
Correspondent Contact Hyeyi Park
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received11/21/2019
Decision Date 05/05/2020
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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