K-number	K191994
Device name	ProFound AI Software V2.1
Applicant	Icad, Inc.
Product code	QDQ
Device class	Class II
Decision date	Oct 4, 2019
Decision	Substantially Equivalent
Regulation	892.2090

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ProFound AI Software V2.1

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