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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K221241
FOIA Releasable 510(k) K221241
Device Name DrAid for Radiology v1
Applicant
VinBrain Joint Stock Company
No 7 Bang Lang 1 Street,
Vinhomes Riverside Ecological Urban Area
Viet Hung Ward, Long Bien District,  VN
Applicant Contact Nguyen Nhat Linh
Correspondent
VinBrain Joint Stock Company
No 7 Bang Lang 1 Street,
Vinhomes Riverside Ecological Urban Area
Viet Hung Ward, Long Bien District,  VN
Correspondent Contact Nguyen Nhat Linh
Regulation Number892.2080
Classification Product Code
QFM  
Date Received04/29/2022
Decision Date 09/01/2022
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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