FDA.report

510(k) K233108

Device
VinDr-Mammo
Applicant
Vinbigdata Joint Stock Company
510(k) number
K233108
Product code
QFM
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-23
Date received
2023-09-27
Regulation
892.2080
Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nguyet (Jun) Phan
Address
Symphony Office Bldg., Chu Huy Man St., Vinhomes Riverside Ecological Urban Area Ha Noi VN 100000 100000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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