TOMTEC Imaging Systems GmbH

Address:Freisinger Strasse 9,UNTERSCHLEISSHEIM,DE

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Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : The IMAGE-ARENA software platform is intended to import, export, store, retrieve 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : LLZ, QIH

Prescription Use : Yes

Device Count : 1

Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : LLZ, QIH

Prescription Use : Yes

Device Count : 1

Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : QIH, LLZ

Prescription Use : Yes

Device Count : 1

Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : LLZ, QIH

Prescription Use : Yes

Device Count : 1

Device Description : TOMTEC-ARENA software is a clinical software package designed for review, quanti 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.

Device Class : 2

Duns Number: 537711462

Premarket Exempt : No

Product Code : QIH, LLZ

Prescription Use : Yes

Device Count : 1