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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
TOMTEC Imaging Systems GmbH
TTA2.52
In Commercial Distribution

  • 04260361440211 ()


  • Radiological PACS software
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
TTA2.42
In Commercial Distribution

  • 04260361440198 ()


  • Radiological PACS software
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
TTA2.41
In Commercial Distribution

  • 04260361440174 ()


  • Radiological PACS software
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
IA4
Not in Commercial Distribution

  • 04260361440150 ()


  • Radiological PACS software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution

  • 04260308110108 ()


  • Radiation therapy software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
In Commercial Distribution



  • Radiation therapy software
The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software
No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software
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.
TOMTEC Imaging Systems GmbH
TTA2.51
In Commercial Distribution

  • 04260361440204 ()


  • Radiological PACS software
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.
TOMTEC Imaging Systems GmbH
TTA2.50
In Commercial Distribution

  • 04260361440181 ()


  • Radiological PACS software
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