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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 K200178
Device Name Ez3D-i /E3
Applicant
Ewoosoft Co., Ltd.
801-Ho, Vatechnetworks Bldg., 13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Young Seok Kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/24/2020
Decision Date 02/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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