K-number	K052632
Device name	VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
Applicant	Vital Images, Inc.
Product code	LLZ
Device class	Class II
Decision date	Dec 15, 2005
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 MEDICAL IMAGE PROCESSING SOFTWARE

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