SIGNA Creator, SIGNA Explorer

System, Nuclear Magnetic Resonance Imaging

GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC)

The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems,llc) with the FDA for Signa Creator, Signa Explorer.

Pre-market Notification Details

Device IDK143251
510k NumberK143251
Device Name:SIGNA Creator, SIGNA Explorer
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactGlen Sabin
CorrespondentGlen Sabin
GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-12
Decision Date2015-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146814 K143251 000
00840682118033 K143251 000
00840682116794 K143251 000
00840682113786 K143251 000
00840682113762 K143251 000

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