K-number	K233108
Device name	VinDr-Mammo
Applicant	Vinbigdata Joint Stock Company
Product code	QFM
Device class	Class II
Decision date	May 23, 2024
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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VinDr-Mammo

Everything you need for a 510(k) submission. Nothing you don't.