NEURO II-S

System, Nuclear Magnetic Resonance Imaging

INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.

The following data is part of a premarket notification filed by Innovative Magnetic Resonance Imaging Systems Inc. with the FDA for Neuro Ii-s.

Pre-market Notification Details

Device IDK050132
510k NumberK050132
Device Name:NEURO II-S
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
ContactThomas M Tsakeris
CorrespondentThomas M Tsakeris
INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-21
Decision Date2005-02-15
Summary:summary

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