Name: Predicase
Price: 199 USD

K-number	K203553
Device name	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Applicant	Canon Medical Systems Corporation
Product code	LNH
Device class	Class II
Decision date	Feb 2, 2021
Decision	Substantially Equivalent
Regulation	892.1000

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

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