GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

Interventional Fluoroscopic X-ray System

GE MEDICAL SYSTEMS SCS

The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Ge Discovery Igs Angiographic,fluoroscopic X-ray System.

Pre-market Notification Details

Device IDK113403
510k NumberK113403
Device Name:GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
ClassificationInterventional Fluoroscopic X-ray System
Applicant GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc,  FR 78530
ContactMichel Genuer
CorrespondentMichel Genuer
GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc,  FR 78530
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-17
Decision Date2012-02-14
Summary:summary

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