Vinbigdata Joint Stock Company
VietnamFDA applicant, unverified
- Devices
- 1
What Vinbigdata Joint Stock Company makes
Vinbigdata produces VinDr-Mammo, an AI-powered diagnostic tool designed for automated analysis of mammogram images to assist radiologists in detecting breast abnormalities.
The company’s portfolio is regulated under FDA’s Class II device classification, with VinDr-Mammo authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
VinDr-Mammo Ref K233108
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Vinbigdata Joint Stock Company have in the registry?
The registry currently lists 1 device for Vinbigdata Joint Stock Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vinbigdata Joint Stock Company's devices?
Among its 1 most recently registered device, Vinbigdata Joint Stock Company has devices listed in FDA 510(k) (1 device).
What risk classes do Vinbigdata Joint Stock Company's devices fall under?
Among its 1 most recently registered device, the classes recorded for Vinbigdata Joint Stock Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vinbigdata Joint Stock Company in the registry?
The most recently registered devices listed for Vinbigdata Joint Stock Company include VinDr-Mammo.