Name: Predicase
Price: 199 USD

K-number	K213305
Device name	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Applicant	Canon Medical Systems Corporation
Product code	LNH
Device class	Class II
Decision date	Dec 1, 2021
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

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