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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 K121650
Device Name S-SCAN
Applicant
ESAOTE, S.P.A.
9001 Wesleyan Road
Suite 200
Indianapolis,  IN  46268
Applicant Contact Allison Scott
Correspondent
ESAOTE, S.P.A.
9001 Wesleyan Road
Suite 200
Indianapolis,  IN  46268
Correspondent Contact Allison Scott
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/05/2012
Decision Date 07/09/2012
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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