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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241543
Device Name DrAid™ for Liver Segmentation
Applicant
VinBrain Joint Stock Company
No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological
Urban Area, Long Bien District, Hanoi
Hanoi,  VN 100000
Applicant Contact Steven Quoc Hung Truong
Correspondent
VinBrain Joint Stock Company
No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological
Urban Area, Long Bien District
Hanoi,  VN 100000
Correspondent Contact Steven Quoc Hung Truong
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/31/2024
Decision Date 12/06/2024
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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