GE SIGNA 3.0T WITH EXCITE MR SYSTEM

System, Nuclear Magnetic Resonance Imaging

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Signa 3.0t With Excite Mr System.

Pre-market Notification Details

Device IDK040444
510k NumberK040444
Device Name:GE SIGNA 3.0T WITH EXCITE MR SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-20
Decision Date2004-04-14
Summary:summary

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