FDA.reportPublic FDA data

TOMTEC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80438361000185293TOMTEC Imaging Systems GMBH1N2020-04-25EDISONSTRASSE 6 UNTERSCHLEISSHEIM Bayern DE 85716
30083496283008349628TOMTEC CORPORATION1Y2020-04-25525 W. Monroe Street Suite 2360 Chicago IL US 60661

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
177951936155170K150122TOMTEC-ARENA TTA2LLZ2015-02-13
177951784040915K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSLLZ2011-04-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ22015-02-13

PMN#

TOMTECP90

1995-09-15

TOMTEC IMAGING SYSTEMS, INC.

GUDID#

IMAGE-ARENA - The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images.

TOMTEC Imaging Systems GmbH

2016-06-06

TOMTEC-ARENA - 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

2020-08-18

TOMTEC-ARENA - 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

2020-12-28

TOMTEC-ARENA - 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

2021-11-19