K-number	K060378
Device name	VITREA2 VERSION 3.8.1
Applicant	Vital Images, Inc.
Product code	LLZ
Device class	Class II
Decision date	Mar 9, 2006
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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VITREA2 VERSION 3.8.1

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