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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
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