Ziehm Vision RFD

System, X-ray, Fluoroscopic, Image-intensified

Ziehm Imaging GmbH

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

Pre-market Notification Details

Device IDK203428
510k NumberK203428
Device Name:Ziehm Vision RFD
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant Ziehm Imaging GmbH Lina-Ammon-Strasse 10 Nuremberg,  DE 90471
ContactStefan Fiedler
CorrespondentSteve Seeman
Ziehm-Orthoscan, Inc. 14555 N. 82nd St. Scottsdale,  AZ  85260
Product CodeJAA  
Subsequent Product CodeOWB
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-20
Decision Date2021-03-17

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