K-number	K183621
Device name	EMMA 1.5T MRI System
Applicant	Time Medical Limited
Product code	LNH
Device class	Class II
Decision date	Feb 22, 2019
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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EMMA 1.5T MRI System

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