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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 K133490
Device Name G-SCAN BRIO
Applicant
Esaote, S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact ALLISON S COTT
Correspondent
Esaote, S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON S COTT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/13/2013
Decision Date 12/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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