K-number	K242203
Device name	BriefCase-Quantification
Applicant	Aidoc Medical , Ltd.
Product code	QIH
Device class	Class II
Decision date	Nov 22, 2024
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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BriefCase-Quantification

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