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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
BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications.
Healthcare professionals are the intended operators of this device.
The Device is intended for use on patients who are 18 years of age or older.
The Device is not intended for critical care.
BIOINTELLISENSE, INC.
SW-BDB
In Commercial Distribution
- 00850005949466 ()
N/A
- Clinical management support software
No Description
KONAN MEDICAL, INC.
CellChek 20-1
In Commercial Distribution
- 04582275250664 ()
- Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CellChek 20
In Commercial Distribution
- 04582275250626 ()
- Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSPC
Not in Commercial Distribution
- 04582275250374 ()
- Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CellChek 20-1 PLUS
In Commercial Distribution
- 04582275250671 ()
- Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CC 20 rc
Not in Commercial Distribution
- 04582275250657 ()
- Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSP
Not in Commercial Distribution
- 04582275250107 ()
- Eye anterior segment analyser
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution
- 00850011790199 ()
MREPLUSV3
- MRI system application software