DICOM Viewer

System, Image Processing, Radiological

Brainlab AG

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

Pre-market Notification Details

Device IDK153653
510k NumberK153653
Device Name:DICOM Viewer
ClassificationSystem, Image Processing, Radiological
Applicant Brainlab AG Kapellenstr. 12 Feldkirchen,  DE 85622
ContactRainer Birkenbach
CorrespondentAlexander Schwiersch
Brainlab AG Kapellenstr. 12 Feldkirchen,  DE 85622
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481139070 K153653 000
04056481007102 K153653 000

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