K-number	K143389
Device name	3.0T GEM RT Open Array
Applicant	Ge Healthcare Coils (Usa Instruments, Inc.)
Product code	MOS
Device class	Class II
Decision date	Mar 6, 2015
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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3.0T GEM RT Open Array

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