K-number	K203042
Device name	Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Dec 10, 2020
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

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