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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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DI Scan
Zetta25 AG
04262352350035
In Commercial Distribution

  • 04262352350035 ()
S3806

  • CAD/CAM software
AIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
AIRAmed GmbH
v2.4.0
In Commercial Distribution

  • 04260723680040 ()


  • Radiological PACS software
No Description
MedicalCommunications GmbH
2.6.5 (Build 2167)
In Commercial Distribution

  • 04260648620060 ()


  • Ophthalmology PACS software
No Description
MedicalCommunications GmbH
2.5
In Commercial Distribution

  • 04260648620015 ()


  • Ophthalmology PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.3
In Commercial Distribution

  • 09358140000048 ()
SCI0001

  • Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.2
In Commercial Distribution

  • 09358140000024 ()
SCI0001

  • Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.1
In Commercial Distribution

  • 09358140000017 ()
SCI0001

  • 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
TTA2.52
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
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