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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
Original Applicant
ESAOTE, S.P.A.
9001 wesleyan road
suite 200
indianapolis,  IN  46268
Original 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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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