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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K211480
Device Name NubeX
Applicant
Techheim Co., Ltd.
Floor 3.4, 21, Banpo-Daero 24-Gil
Seoul,  KR 06648
Applicant Contact Weon Yong Lee
Correspondent
Kmc, Inc.
Rm. # 1709, 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact JeongKeun Kim
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/12/2021
Decision Date 07/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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