GE 3.0T SIGNA INFINITY TWINSPEED 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 3.0t Signa Infinity Twinspeed With Excite Mr System.

Pre-market Notification Details

Device IDK030874
510k NumberK030874
Device Name:GE 3.0T SIGNA INFINITY TWINSPEED 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 Received2003-03-20
Decision Date2003-03-28
Summary:summary

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