K-number	K231025
Device name	EFAI NeuroSuite CT ICH Assessment System
Applicant	Ever Fortune.Ai, Co., Ltd.
Product code	QAS
Device class	Class II
Decision date	Oct 4, 2023
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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EFAI NeuroSuite CT ICH Assessment System

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