MR RADIATION ONCOLOGY OPTIONS

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 Mr Radiation Oncology Options.

Pre-market Notification Details

Device IDK102155
510k NumberK102155
Device Name:MR RADIATION ONCOLOGY OPTIONS
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactTracey Fox
CorrespondentTracey Fox
GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-30
Decision Date2010-08-31
Summary:summary

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