Ziehm 8000

Interventional Fluoroscopic X-ray System

Ziehm Imaging GmbH

The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm 8000.

Pre-market Notification Details

Device IDK190497
501k NumberK190497
Device Name:Ziehm 8000
ClassificationInterventional Fluoroscopic X-ray System
Applicant Ziehm Imaging GmbH Donaustrasse 31 Nuremberg,  DE 90451
ContactSteve Seeman
CorrespondentSteve Seeman
Ziehm Imaging, Inc. 6280 Hazeltine National Drive Orlando,  FL  32822
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-28
Decision Date2019-11-20

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