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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 K213801
Device Name Veuron-Brain-pAb2
Applicant
Heuron Co., Ltd.
10th Floor, 7, Mirae-Ro, Namdong-Gu
Incheon,  KR 21558
Applicant Contact Dong Hoon Shin
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln.
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2021
Decision Date 02/04/2022
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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