Name: Predicase
Price: 199 USD

K-number	K182223
Device name	Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Applicant	Canon Medical Systems, USA
Product code	JAK
Device class	Class II
Decision date	Sep 14, 2018
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 Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

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