TOMTEC-ARENA

GUDID 04260361440174

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.

TOMTEC Imaging Systems GmbH

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID04260361440174
NIH Device Record Keycbd25889-a4d1-4ea4-a237-d8be3690b10c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOMTEC-ARENA
Version Model NumberTTA2.41
Company DUNS537711462
Company NameTOMTEC Imaging Systems GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260361440174 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-05
Device Publish Date2020-12-28

On-Brand Devices [TOMTEC-ARENA]

04260361440167TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
04260361440174TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
04260361440198TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
04260361440181TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
04260361440204TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep
04260361440211TOMTEC-ARENA software is a clinical software package designed for review, quantification and rep

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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