Name: Predicase
Price: 199 USD

K-number	K160315
Device name	I4 (Integrated Intelligent Imaging Informatics) system
Applicant	Philips Medical Systems Nederland B.V.
Product code	LLZ
Device class	Class II
Decision date	Feb 19, 2016
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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I4 (Integrated Intelligent Imaging Informatics) system

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