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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 K181964
Device Name JiveX
Applicant
Visus Health IT GmbH
Gesundheitscampus-Sued 15-17
Bochum,  DE 44801
Applicant Contact Axel Schreiber
Correspondent
Visus Health IT GmbH
Gesundheitscampus-Sued 15-17
Bochum,  DE 44801
Correspondent Contact Axel Schreiber
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/23/2018
Decision Date 10/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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