K-number	K170177
Device name	Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
Applicant	Toshibamedical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Jun 30, 2017
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

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