System, Image Processing, Radiological

Ewoosoft Co., Ltd

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

Pre-market Notification Details

Device IDK211791
510k NumberK211791
Device Name:Ez3D-i/E3
ClassificationSystem, Image Processing, Radiological
Applicant Ewoosoft Co., Ltd 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactYoung Seok Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine,  CA  92612
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-10
Decision Date2021-08-20

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