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

Canon Medical Systems Corporation · K230355 · 2023-08-30

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K230355) with a decision date of 2023-08-30. Review panel: Radiology.

FDA submission numberK230355
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2023-08-30
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)202
Applicant countryJP

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.