K-number	K970990
Device name	GYREX PRIMA 1TG 1.0T MRI SYSTEM
Applicant	Elscint Mr, Inc.
Product code	LNH
Device class	Class II
Decision date	Aug 25, 1997
Decision	Substantially Equivalent
Regulation	892.1000

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View the full FDA submission: accessdata.fda.gov

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GYREX PRIMA 1TG 1.0T MRI SYSTEM

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