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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 - 04260361440143

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
In Commercial Distribution

  • 04260361440143 ()


  • Radiological PACS software

Prelude - 04260308110108

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

Prelude - 04260308110092

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

Prelude - 04260308110078

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

JiveX - 04260632470084

Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
VISUS Health IT GmbH
5.4+
In Commercial Distribution

  • 04260632470084 ()


  • Radiological PACS software

JiveX - 04260632470039

Version 5.3 includes all minor versions and patch levels of 5.3
VISUS Health IT GmbH
5.3
Not in Commercial Distribution

  • 04260632470039 ()


  • Radiological PACS software

JiveX - 04260632470022

Version 5.2 includes all minor versions and patch levels of 5.2
VISUS Health IT GmbH
5.2
Not in Commercial Distribution

  • 04260632470022 ()


  • Radiological PACS software

JiveX - 04260632470015

Version 5.1 includes all minor versions and patch levels of 5.1
VISUS Health IT GmbH
5.1
Not in Commercial Distribution

  • 04260632470015 ()


  • Radiological PACS software

VeriSuite - 04260308110023

No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software

Ashvins variant HEYEX 2 / HEYEX PACS - 04260648620060

No Description
MedicalCommunications GmbH
2.6.5 (Build 2167)
In Commercial Distribution

  • 04260648620060 ()


  • Ophthalmology PACS software
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