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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 K233108
Device Name VinDr-Mammo
Applicant
Vinbigdata Joint Stock Company
Symphony Office Bldg., Chu Huy Man St.,
Vinhomes Riverside Ecological Urban Area
Ha Noi,  VN 100000
Applicant Contact Nguyet (Jun) Phan
Correspondent
Vinbigdata Joint Stock Company
Symphony Office Bldg., Chu Huy Man St.,
Vinhomes Riverside Ecological Urban Area
Ha Noi,  VN 100000
Correspondent Contact Nguyet (Jun) Phan
Regulation Number892.2080
Classification Product Code
QFM  
Date Received09/27/2023
Decision Date 05/23/2024
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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