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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 K142750
Device Name JiveX
Applicant
VISUS TECHNOLOGY TRANSFER GMBH
Universitatsstrasse 136
bochum,  DE 44797
Applicant Contact axel schreiber
Correspondent
VISUS TECHNOLOGY TRANSFER GMBH
Universitatsstrasse 136
bochum,  DE 44797
Correspondent Contact axel schreiber
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/24/2014
Decision Date 06/26/2015
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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