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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
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution
- D438506DNBUS0 ()
- Multiple vital physiological parameter monitoring system, clinical
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
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621113 ()
- 04719875621116 ()
UT-0222-KOL
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621106 ()
- 04719875621109 ()
UT-0222-50
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621083 ()
- 04719875621086 ()
UT-0222-1Y
- Ultrasound imaging system application software
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NTR-04
In Commercial Distribution
- 04719878713542 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NTR-02
In Commercial Distribution
- 04719878713528 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NGC-03
In Commercial Distribution
- 04719878713511 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-RTR-02
In Commercial Distribution
- 04719878713337 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-DPS-04
In Commercial Distribution
- 04719878713207 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-CNS-02
In Commercial Distribution
- 04719878713085 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-SSG-02
In Commercial Distribution
- 04719878713078 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-DPS-00
In Commercial Distribution
- 04719878713016 ()
- Surgical planning/navigation-enhancement system
AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
AMCAD BIOMED CORPORATION
1.0
In Commercial Distribution
- 04719875623103 ()
UO-0102
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 04719875621130 ()
UT-0222-1Q
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621120 ()
- 04719875621123 ()
UT-0222-1P
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621090 ()
- 04719875621093 ()
UT-0222-1000
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621021 ()
- 04719875621024 ()
UT-0222-500
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621014 ()
- 04719875621017 ()
UT-0222-D
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 04719875621000 ()
- 14719875621007 ()
UT-0222
- Ultrasound imaging system application software
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-LTP-01
In Commercial Distribution
- 04719878713801 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-ITH-01
In Commercial Distribution
- 04719878713733 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NGC-04
In Commercial Distribution
- 04719878713573 ()
- Surgical planning/navigation-enhancement system
Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-681RA
In Commercial Distribution
- 04931921131640 ()
PU-681RA
- Centralized patient monitor
Additional alarm indicator unit, cable length
NIHON KOHDEN CORPORATION
YS-098P2
In Commercial Distribution
- 04931921114858 ()
YS-098P2
- Centralized patient monitor
Additional alarm indicator unit, cable length
NIHON KOHDEN CORPORATION
YS-098P1
In Commercial Distribution
- 04931921114841 ()
YS-098P1
- Centralized patient monitor
VL cable set (Second), cable length
NIHON KOHDEN CORPORATION
YS-097P9
In Commercial Distribution
- 04931921114834 ()
YS-097P9
- Centralized patient monitor
VL cable set (Second), cable length
NIHON KOHDEN CORPORATION
YS-097P8
In Commercial Distribution
- 04931921114827 ()
YS-097P8
- Centralized patient monitor
VL cable set (Main), cable length
NIHON KOHDEN CORPORATION
YS-097P6
In Commercial Distribution
- 04931921114810 ()
YS-097P6
- Centralized patient monitor
VL cable set (Main), cable length
NIHON KOHDEN CORPORATION
YS-097P5
In Commercial Distribution
- 04931921114803 ()
YS-097P5
- Centralized patient monitor
POWER SUPPLY KIT FOR WS-960P
NIHON KOHDEN CORPORATION
SC-611R
In Commercial Distribution
- 04931921114445 ()
SC-611RA
- Centralized patient monitor
Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-621R
In Commercial Distribution
- 04931921114131 ()
PU-621RA
- Centralized patient monitor
Alarm indicator, cable length
NIHON KOHDEN CORPORATION
YL-612P
In Commercial Distribution
- 04931921107805 ()
YL-612P
- Centralized patient monitor