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

System, Nuclear Magnetic Resonance Imaging

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Vantage Orian 1.5t, Mrt-1550, V6.0 With Aice Reconstruction Processing Unit For Mr.

Pre-market Notification Details

Device IDK210340
510k NumberK210340
Device Name:Vantage Orian 1.5T, MRT-1550, V6.0 With AiCE Reconstruction Processing Unit For MR
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentJanine F. Reyes
Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin,  CA  92780
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-04-01

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