K-number	K183046
Device name	Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Jun 12, 2019
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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Aquilion ONE (TSX-305A/6) V8.9 with AiCE

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