Name: Predicase
Price: 199 USD

K-number	K100113
Device name	VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
Applicant	Sentinelle Medical, Inc.
Product code	MOS
Device class	Class II
Decision date	Apr 22, 2010
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51

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