Name: Predicase
Price: 199 USD

K-number	K082485
Device name	MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
Applicant	Neusoft Medical Systems Co., Ltd.
Product code	LNH
Device class	Class II
Decision date	Sep 9, 2008
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A

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