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 Ezmobile.

Pre-market Notification Details

Device IDK192098
510k NumberK192098
Device Name:EzMobile
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. 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 Received2019-08-05
Decision Date2020-01-20


Device IdentifiersubmissionNumberSupplement
08800019700142 K192098 000

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