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 IDK202948
510k NumberK202948
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2020-10-22

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