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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 K120187
Device Name MULTI-MODALITY IMAGE FUSION
Original Applicant
IGT LLC DBA EIGEN
13366 grass valley avenue
grass valley,  CA  95945
Original Contact william mandel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/23/2012
Decision Date 04/06/2012
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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