Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation · K193097 · 2020-07-14

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K193097) with a decision date of 2020-07-14. Review panel: Radiology.

FDA submission numberK193097
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2020-07-14
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)250
Applicant countryJP

Official FDA database record · FDA AI-enabled device list

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