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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
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
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