1.5T OPTIMA MR430S

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for 1.5t Optima Mr430s.

Pre-market Notification Details

Device IDK103238
510k NumberK103238
Device Name:1.5T OPTIMA MR430S
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC 301 BALLARDVALE STREET SUITE 4 Wilmington,  MA  01887
ContactNorma Lemay
CorrespondentNorma Lemay
GE MEDICAL SYSTEMS, LLC 301 BALLARDVALE STREET SUITE 4 Wilmington,  MA  01887
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-02
Decision Date2011-02-11
Summary:summary

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