TOMTEC-ARENA

Automated Radiological Image Processing Software

TOMTEC Imaging Systems GmbH

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

Pre-market Notification Details

Device IDK213544
510k NumberK213544
Device Name:TOMTEC-ARENA
ClassificationAutomated Radiological Image Processing Software
Applicant TOMTEC Imaging Systems GmbH Freisinger Strasse 9 Unterschleissheim,  DE 85716
ContactMarc Bergenthal
CorrespondentMarc Bergenthal
TOMTEC Imaging Systems GmbH Freisinger Strasse 9 Unterschleissheim,  DE 85716
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-08
Decision Date2022-01-06

Trademark Results [TOMTEC-ARENA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOMTEC-ARENA
TOMTEC-ARENA
86004990 4566739 Live/Registered
TomTec Imaging Systems GmbH
2013-07-09

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