Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

System, Image Processing, Radiological

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio.

Pre-market Notification Details

Device IDK212420
510k NumberK212420
Device Name:Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
ClassificationSystem, Image Processing, Radiological
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 80809
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 80809
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2021-12-16

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