IDEAL SOFTWARE OPTION FOR GE MR SCANNERS

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 Ideal Software Option For Ge Mr Scanners.

Pre-market Notification Details

Device IDK072998
510k NumberK072998
Device Name:IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactMark M Stauffer
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-10-24
Decision Date2007-11-01
Summary:summary

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