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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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Software tool to facilitate the import and visualization of multi slice, spin echo MRI data sets encompassing the liver and cardiac tissue, with functionality independent of the MRI equipment vendor. The operational principle is based on fitting signal decay curves to the image signal intensities at the different echo times for the MR data set on a voxel by voxel (3 D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo and fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel by voxel (3 D pixel) basis to determine the signal decay rate (R2*) and time (T2*) The obtained results can be used for the following purposes: 1. Supporting clinical diagnoses about the status of liver iron concentration and cardiac iron. 2. Supporting the subsequent clinical decision making processes. 3. Supporting the use in clinical research trials, directed at studying changes in liver iron concentration as a result of interventions. 4. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing images and performing region of interest analysis.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
4.0.0
In Commercial Distribution

  • 09355529000002 ()


  • MRI system application software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software
Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software
No Description
KONICA MINOLTA, INC.
AEYC
In Commercial Distribution

  • 04560141951914 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
AEVE
In Commercial Distribution

  • 04560141951426 ()


  • Diagnostic x-ray digital imaging system workstation application software
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