K-number	K143586
Device name	FACT Medical Imaging Sysytem
Applicant	Dexin Medical Imaging Technology Co., Ltd.
Product code	LLZ
Device class	Class II
Decision date	Sep 2, 2015
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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FACT Medical Imaging Sysytem

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