Signa Voyager, Signa Voyager Quantum

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 Voyager, Signa Voyager Quantum.

Pre-market Notification Details

Device IDK192426
510k NumberK192426
Device Name:Signa Voyager, Signa Voyager Quantum
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin,  CN 300308
ContactYuan Ma
CorrespondentYuan Ma
GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin,  CN 300308
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-05
Decision Date2019-10-01

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