K-number	K103335
Device name	GEM OPTION FOR 1.5 MRI SYSTEMS
Applicant	GE Healthcare
Product code	MOS
Device class	Class II
Decision date	Mar 7, 2011
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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GEM OPTION FOR 1.5 MRI SYSTEMS

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