K-number	K221241
Device name	DrAid for Radiology v1
Applicant	Vinbrain Joint Stock Company
Product code	QFM
Device class	Class II
Decision date	Sep 1, 2022
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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DrAid for Radiology v1

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