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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 K171199
Device Name AVIEW
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
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/24/2017
Decision Date 10/31/2018
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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