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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 Dr.
Indianpolis,  IN  46250
Applicant Contact COLLEEN J DENSMORE
Correspondent
Esaote, S.p.A.
7992 Castleway Dr.
Indianpolis,  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
Predetermined Change
Control Plan Authorized		 No
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