SIGNA Artist

System, Nuclear Magnetic Resonance Imaging

GE Healthcare (Tianjin) Company Limited

The following data is part of a premarket notification filed by Ge Healthcare (tianjin) Company Limited with the FDA for Signa Artist.

Pre-market Notification Details

Device IDK202238
510k NumberK202238
Device Name:SIGNA Artist
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE Healthcare (Tianjin) Company Limited No. 266 Jingsan Road,Tianjin Airport Economic Area Tianjin,  CN 300308
ContactQiang Ding
CorrespondentGlen Sabin
GE Healthcare (GE Medical System, LLC) 3200 N Grandview Blvd. Waukesha,  WI  53188
Product CodeLNH  
Subsequent Product CodeLNI
Subsequent Product CodeMOS
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2020-09-04

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