TOMTEC-ARENA
TOMTEC Imaging Systems GmbH
TOMTEC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8043836 | 1000185293 | TOMTEC Imaging Systems GMBH | 1 | N | 2020-04-25 | EDISONSTRASSE 6 UNTERSCHLEISSHEIM Bayern DE 85716 |
| 3008349628 | 3008349628 | TOMTEC CORPORATION | 1 | Y | 2020-04-25 | 525 W. Monroe Street Suite 2360 Chicago IL US 60661 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17795 | 1936155170 | K150122 | TOMTEC-ARENA TTA2 | LLZ | 2015-02-13 |
| 17795 | 1784040915 | K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | 2011-04-08 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 2 | 2015-02-13 |
PMN#
TOMTEC-ARENA
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA TTA2
TOMTEC IMAGING SYSTEMS, GMBH
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
TOMTEC IMAGING SYSTEMS, GMBH
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
TOMTEC IMAGING SYSTEMS, GMBH
4D LV-ANALYSIS 3.0
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH
4D SONO-SCAN 1.0
TOMTEC IMAGING SYSTEMS, GMBH
4D MV-ASSESSMENT 2.0
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA APPLICATIONS
Tomtec Imaging Systems GmbH
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X
Tomtec Imaging Systems GmbH
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
TOMTEC IMAGING SYSTEMS, GMBH
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
TOMTEC IMAGING SYSTEMS, GMBH
ECHOCOM, IMAGECOM, DOKUCOM
TOMTEC IMAGING SYSTEMS, GMBH
ECHO VIEW, EASY VIEW, OMNI VIEW
TOMTEC IMAGING SYSTEMS, GMBH
ECHO SCAN, EASY SCAN
TOMTEC IMAGING SYSTEMS, GMBH
TOMTEC ECHO-SCAN
TOMTEC IMAGING SYSTEMS, INC.
TOMTECP90
TOMTEC IMAGING SYSTEMS, INC.
TOMTEC ECHO-VIEW
TOMTEC TOMOGRAPHIC TECHNOLOGIES GMBH
GUAMSTAINER
TOMTEC
AUTOSTREAKER
TOMTEC
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.
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.
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.
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.
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.
2021-11-19
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.
2022-01-21
TOMTEC-ARENA - TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images.
2022-08-02
TOMTEC-ARENA - TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images.
2023-09-06