Aquilion Prime SP (TSX-303B8) V10.2 With AiCE-i

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 Prime Sp (tsx-303b8) V10.2 With Aice-i.

Pre-market Notification Details

Device IDK192832
510k NumberK192832
Device Name:Aquilion Prime SP (TSX-303B8) V10.2 With AiCE-i
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-02
Decision Date2020-02-21

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