Name: Predicase
Price: 199 USD

K-number	K102344
Device name	MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
Applicant	Philips Medical Systems Nederland B.V.
Product code	LNH
Device class	Class II
Decision date	Nov 9, 2010
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS

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