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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 K142421
Device Name G-scan Brio
Applicant
ESAOTE, S.P.A.
VIA SIFFREDI 58
GENOVA,  IT 16153
Applicant Contact Donatella Ragghianti
Correspondent
NAVIGANT CONSULTING, INC.
9001 WESLEYAN ROAD, SUITE 200
INDIANAPOLIS,  IN  46268
Correspondent Contact Allison Scott
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/28/2014
Decision Date 04/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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