Name: Predicase
Price: 199 USD

K-number	K112112
Device name	SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
Applicant	Sentinel Medical, Inc.
Product code	MOS
Device class	Class II
Decision date	Aug 25, 2011
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS

Everything you need for a 510(k) submission. Nothing you don't.