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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K041145
Device Name MODIFICATION TO E-SCAN XQ MRI SYSTEM
Applicant
ESAOTE S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/03/2004
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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