NEURO II

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.

Pre-market Notification Details

Device IDK002964
510k NumberK002964
Device Name:NEURO II
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 11605 HITCHING POST LN. Rockville,  MD  20852
ContactJoel S Faden
CorrespondentJoel S Faden
INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 11605 HITCHING POST LN. Rockville,  MD  20852
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-22
Decision Date2000-12-19

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