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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 K080968
Device Name S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
Applicant
ESAOTE S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL,  IN  46032
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/04/2008
Decision Date 04/29/2008
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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