SIGNA Premier

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 Premier.

Pre-market Notification Details

Device IDK193282
510k NumberK193282
Device Name:SIGNA Premier
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  
Subsequent Product CodeLNI
Subsequent Product CodeMOS
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-04-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278010797 K193282 000

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