Alphenix, INFX-8000V/B, /S, V9.1

Interventional Fluoroscopic X-ray System

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Alphenix, Infx-8000v/b, /s, V9.1.

Pre-market Notification Details

Device IDK203551
510k NumberK203551
Device Name:Alphenix, INFX-8000V/B, /S, V9.1
ClassificationInterventional Fluoroscopic X-ray System
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentPaul Biggins
Canon Medical Systems USA, INC. 2441 Michelle Drive Tustin,  CA  92780
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2020-12-18

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