System, Image Processing, Radiological

TechHeim Co., Ltd

The following data is part of a premarket notification filed by Techheim Co., Ltd with the FDA for Nubex.

Pre-market Notification Details

Device IDK211480
510k NumberK211480
Device Name:NubeX
ClassificationSystem, Image Processing, Radiological
Applicant TechHeim Co., Ltd Floor 3.4, 21, Banpo-daero 24-gil Seoul,  KR 06648
ContactWeon Yong Lee
CorrespondentJeongkeun Kim
KMC, Inc. Room No. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul,  KR 08390
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-12
Decision Date2021-07-08

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