Thoracic VCAR With GSI Pulmonary Perfusion

System, Image Processing, Radiological

GE Medical Systems SCS

The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Thoracic Vcar With Gsi Pulmonary Perfusion.

Pre-market Notification Details

Device IDK183210
510k NumberK183210
Device Name:Thoracic VCAR With GSI Pulmonary Perfusion
ClassificationSystem, Image Processing, Radiological
Applicant GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
ContactPeter Uhlir
CorrespondentHelen Peng
GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha,  WI  53188
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-03-29
Summary:summary

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