3D ASL

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for 3d Asl.

Pre-market Notification Details

Device IDK092925
510k NumberK092925
Device Name:3D ASL
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactYuan Ma
CorrespondentYuan Ma
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 Received2009-09-23
Decision Date2010-01-06
Summary:summary

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