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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 K122006
Device Name G-SCAN BRIO
Applicant
Esaote, S.p.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
Esaote, S.p.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LLZ   MOS  
Date Received07/09/2012
Decision Date 08/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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