MODIFICATION TO E-SCAN XQ MRI SYSTEM

Coil, Magnetic Resonance, Specialty

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 Mri System.

Pre-market Notification Details

Device IDK041145
510k NumberK041145
Device Name:MODIFICATION TO E-SCAN XQ MRI SYSTEM
ClassificationCoil, Magnetic Resonance, Specialty
Applicant ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
ContactCarri Graham
CorrespondentCarri Graham
ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-03
Decision Date2004-05-14
Summary:summary

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