Name: Predicase
Price: 199 USD

K-number	K232835
Device name	Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Apr 2, 2024
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-308A/3) V1.4 with PIQE Reconstruction System

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