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Standalone software application to facilitate the import and visualization of multi slice, gradient echo MRI data sets encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
V1.1.0
In Commercial Distribution
- 09355529000040 ()
- MRI system application software
Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results.
HepaFat-AI is intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF).
It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
HepaFat-AI is indicated to:
• Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease;
• Monitor liver fat content in patients undergoing weight loss management;
• Aid in the assessment and screening of living donors for liver transplant.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
V1.0.0
Not in Commercial Distribution
- 09355529000019 ()
- MRI system application software
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
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.
The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.
The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.
FerriSmart is indicated to:
• measure liver iron concentration in individuals with confirmed or suspected systemic iron overload
• monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions
• aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v01
In Commercial Distribution
- 09369998038619 ()
- MRI system application software
Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution
- 04987670100451 ()
- Diagnostic x-ray digital imaging system workstation application software
GRAFT SIZER
STRYKER CORPORATION
2000-004-051
In Commercial Distribution
- 04546540790989 ()
2000-004-051
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 8MM
STRYKER CORPORATION
234-020-087
In Commercial Distribution
- 04546540755889 ()
- Lumen/Inner Diameter: 8.0 Millimeter
234-020-087
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 7MM
STRYKER CORPORATION
234-020-086
In Commercial Distribution
- 04546540755872 ()
- Lumen/Inner Diameter: 7.0 Millimeter
234-020-086
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 6MM
STRYKER CORPORATION
234-020-085
In Commercial Distribution
- 04546540755865 ()
- Lumen/Inner Diameter: 6.0 Millimeter
234-020-085
- Ligament graft sizer, noninvasive
DRILL GUIDE/GRAFT SIZER, MODULAR ACL WORKSTATION
STRYKER CORPORATION
234-010-517
In Commercial Distribution
- 04546540755124 ()
234-010-517
- Ligament graft sizer, noninvasive