DISCOVERY MR750W 3.0T

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 Discovery Mr750w 3.0t.

Pre-market Notification Details

Device IDK130115
510k NumberK130115
Device Name:DISCOVERY MR750W 3.0T
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactMichelle Huettner
CorrespondentMichelle Huettner
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 Received2013-01-16
Decision Date2013-05-23
Summary:summary

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