Aquilion ONE (TSX-306A/3) V10.4 With Spectral Imaging System

System, X-ray, Tomography, Computed

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aquilion One (tsx-306a/3) V10.4 With Spectral Imaging System.

Pre-market Notification Details

Device IDK203225
510k NumberK203225
Device Name:Aquilion ONE (TSX-306A/3) V10.4 With Spectral Imaging System
ClassificationSystem, X-ray, Tomography, Computed
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo
Canon Medical Systems USA 2441 Michelle Drive Tustin,  CA  92780
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-03-24

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