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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K122205
Device Name EXINI
Original Applicant
EXINI DIAGNOSTICS AB
9001 wesleyan road
suite 200
inndianapolis,  IN  46268
Original Contact allison scott
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/25/2012
Decision Date 08/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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