GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge 0.35t Signa Ovation With Excite Mr System.

Pre-market Notification Details

Device IDK053009
510k NumberK053009
Device Name:GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-26
Decision Date2005-11-17
Summary:summary

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