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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 K162008
Device Name JiveX
Applicant
VISUS TECHNOLOGY TRANSFER GMBH
Universitaetsstrasse 136
bochum,  DE 44799
Applicant Contact axel schreiber
Correspondent
VISUS TECHNOLOGY TRANSFER GMBH
Universitaetsstrasse 136
bochum,  DE 44799
Correspondent Contact axel schreiber
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/20/2016
Decision Date 09/16/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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