IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS

System, Image Processing, Radiological

TOMTEC IMAGING SYSTEMS, GMBH

The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Image-arena Applications And Research-arena Applications.

Pre-market Notification Details

Device IDK071232
510k NumberK071232
Device Name:IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
ClassificationSystem, Image Processing, Radiological
Applicant TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim,  DE D-85716
ContactInge Scheidt
CorrespondentInge Scheidt
TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim,  DE D-85716
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-03
Decision Date2007-06-20
Summary:summary

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