K-number	K212624
Device name	EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Applicant	Ever Fortune.Ai, Co., Ltd.
Product code	QIH
Device class	Class II
Decision date	Apr 4, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

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