K-number	K201836
Device name	Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Jan 12, 2021
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

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