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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 K201710
Device Name A View LCS
Applicant
Coreline Soft Co., Ltd.
4,5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil,
Mapo-gu
Seoul,  KR 03991
Applicant Contact Hye Yi Park
Correspondent
Coreline Soft Co., Ltd.
4,5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil,
Mapo-gu
Seoul,  KR 03991
Correspondent Contact Hye Yi Park
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received06/23/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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