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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 K063207
Device Name S-SCAN MRI SYSTEM
Applicant
ESAOTE, S.P.A.
11460 N MERIDIAN ST., STE 150
CARMEL,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE, S.P.A.
11460 N MERIDIAN ST., STE 150
CARMEL,  IN  46032
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/23/2006
Decision Date 11/09/2006
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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