TOMTEC-ARENA
TOMTEC Imaging Systems GmbH
TOMTEC Imaging Systems GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8043836 | 1000185293 | TOMTEC Imaging Systems GMBH | 1 | N | 2026-01-01 | Freisinger Strasse 9 UNTERSCHLEISSHEIM Bavaria DE 85716 |
| 8043836 | 1000185293 | TOMTEC Imaging Systems GMBH | 1 | N | 2020-04-25 | EDISONSTRASSE 6 UNTERSCHLEISSHEIM Bayern DE 85716 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 280670 | 1380672905 | K241659 | Ultrasound Workspace (UWS 6.0) | QIH | 2025-02-10 |
| 280670 | 1177659823 | K213544 | TOMTEC-ARENA | QIH | 2022-01-06 |
| 280670 | 1181615785 | K201632 | TOMTEC-ARENA | LLZ | 2020-08-14 |
| 280670 | 1758960621 | K150122 | TOMTEC-ARENA TTA2 | LLZ | 2015-02-13 |
| 17795 | 1936155170 | K150122 | TOMTEC-ARENA TTA2 | LLZ | 2015-02-13 |
| 280670 | 1447311808 | K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | 2011-04-08 |
| 17795 | 1784040915 | K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | 2011-04-08 |
Product Codes Associated With Registrations#
PMN#
TOMTEC-ARENA
TOMTEC Imaging Systems GmbH
IMAGE-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
GUDID#
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.
2023-09-06
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.
2022-08-02
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 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. 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.
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.
2016-06-06
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