Ez3D-i /E3

System, Image Processing, Radiological

Ewoo Soft Co., Ltd.

The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ez3d-i /e3.

Pre-market Notification Details

Device IDK173863
510k NumberK173863
Device Name:Ez3D-i /E3
ClassificationSystem, Image Processing, Radiological
Applicant Ewoo Soft Co., Ltd. 801-ho, Vatechnetworks Bldg., Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactYoung Seok Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 690 Roosevelt Irvine,  CA  92620
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-20
Decision Date2018-02-23
Summary:summary

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