MRI- FLOW ANALYTICAL SOFTWARE PACKAGE

System, Nuclear Magnetic Resonance Imaging

MEDIS MEDICAL IMAGING SYSTEMS, B.V.

The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Mri- Flow Analytical Software Package.

Pre-market Notification Details

Device IDK994282
510k NumberK994282
Device Name:MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden,  NL 2333 Aa
ContactJ.i. Hollander
CorrespondentJ.i. Hollander
MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden,  NL 2333 Aa
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-20
Decision Date2000-03-02
Summary:summary

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