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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K231757
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.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/16/2023
Decision Date 07/14/2023
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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