DIGITAL LIGHTBOX

System, Image Processing, Radiological

BRAINLAB AG

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

Pre-market Notification Details

Device IDK093117
510k NumberK093117
Device Name:DIGITAL LIGHTBOX
ClassificationSystem, Image Processing, Radiological
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-02
Decision Date2009-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481006877 K093117 000
04056481006846 K093117 000
04056481001797 K093117 000
04056481000431 K093117 000
04056481000363 K093117 000
04056481000356 K093117 000

Trademark Results [DIGITAL LIGHTBOX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIGITAL LIGHTBOX
DIGITAL LIGHTBOX
77332451 3972062 Dead/Cancelled
BrainLAB AG
2007-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.