K-number	K192383
Device name	BriefCase
Applicant	Aidoc Medical , Ltd.
Product code	QAS
Device class	Class II
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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BriefCase

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