JiveX (Model Number / Release: 5.3)

System, Image Processing, Radiological

Visus Health IT GmbH

The following data is part of a premarket notification filed by Visus Health It Gmbh with the FDA for Jivex (model Number / Release: 5.3).

Pre-market Notification Details

Device IDK212321
510k NumberK212321
Device Name:JiveX (Model Number / Release: 5.3)
ClassificationSystem, Image Processing, Radiological
Applicant Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum,  DE 44801
ContactAxel Schreiber
CorrespondentAxel Schreiber
Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum,  DE 44801
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-26
Decision Date2021-09-23

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