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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 K151668
Device Name S-scan
Applicant
Esaote, S.p.A.
Via Stiffredi 58
Genova,  IT 16153
Applicant Contact DONATELLA RAGGHIANTI
Correspondent
Navigant Consulting, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact Kelli Anderson
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/19/2015
Decision Date 09/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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