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 Ezortho.

Pre-market Notification Details

Device IDK192888
510k NumberK192888
Device Name:EzOrtho
ClassificationSystem, Image Processing, Radiological
Applicant Ewoo Soft 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 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-10
Decision Date2020-03-13

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