K-number	K161009
Device name	Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
Applicant	Toshibamedical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Jul 22, 2016
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

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