Alphenix, INFX-8000H/B, V8.0

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-8000h/b, V8.0.

Pre-market Notification Details

Device IDK182546
510k NumberK182546
Device Name:Alphenix, INFX-8000H/B, V8.0
ClassificationInterventional Fluoroscopic X-ray System
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 CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-17
Decision Date2018-10-17
Summary:summary

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