Elements Viewer

System, Image Processing, Radiological

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Elements Viewer.

Pre-market Notification Details

Device IDK191014
510k NumberK191014
Device Name:Elements Viewer
ClassificationSystem, Image Processing, Radiological
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactOliver Fleig
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-17
Decision Date2020-01-23

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