Ez3D-i/E3

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 IDK222069
510k NumberK222069
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-14
Decision Date2022-09-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019700340 K222069 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.