MODIFICATION TO E-SCAN XQ

System, Nuclear Magnetic Resonance Imaging

ESAOTE S.P.A.

The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Modification To E-scan Xq.

Pre-market Notification Details

Device IDK032121
510k NumberK032121
Device Name:MODIFICATION TO E-SCAN XQ
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
ContactColleen J Densmore
CorrespondentColleen J Densmore
ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-09
Decision Date2003-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304453327 K032121 000
08056304453310 K032121 000

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