K-number	K103465
Device name	SYNAPSE 3D CARDIAC TOOLS
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	LLZ
Device class	Class II
Decision date	Jan 31, 2011
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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SYNAPSE 3D CARDIAC TOOLS

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