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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K032121
Device Name MODIFICATION TO E-SCAN XQ
Applicant
ESAOTE S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN J DENSMORE
Correspondent
ESAOTE S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN J DENSMORE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/09/2003
Decision Date 08/13/2003
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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