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Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230355
510(k) Type
Traditional
Applicant
Canon Medical Systems Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/30/2023
Days to Decision
202 days
Submission Type
Summary