SIGNA 7.0T

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 Signa 7.0t.

Pre-market Notification Details

Device IDK211118
510k NumberK211118
Device Name:SIGNA 7.0T
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE Medical Systems, LLC 3200 Grandview Blvd Waukesha,  WI  53188
ContactBrian R. Zielski
CorrespondentBrian R. Zielski
GE Medical Systems, LLC 3200 Grandview Blvd Waukesha,  WI  53188
Product CodeLNH  
Subsequent Product CodeLNI
Subsequent Product CodeMOS
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-15
Decision Date2021-05-13

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