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suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution
- 00850001088008 ()
- MRI system application software
No Description
KONICA MINOLTA, INC.
A4C1
In Commercial Distribution
- 04560141945166 ()
- Diagnostic x-ray digital imaging system workstation 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
No Description
KONICA MINOLTA, INC.
AEVD
In Commercial Distribution
- 04560141951419 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
AE9A
In Commercial Distribution
- 04560141950849 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
ACDY
In Commercial Distribution
- 04560141947788 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
ACDX
In Commercial Distribution
- 04560141947771 ()
- Diagnostic x-ray digital imaging system workstation 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
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
- 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
- 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
- 14719875621083 ()
- 04719875621086 ()
UT-0222-1Y
- 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
Standalone software as medical device (SaMD) 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.
HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading.
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.
HepaFatSmart is indicated to:
• Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease;
• Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis.
• Support the subsequent clinical decision-making processes for patients
Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v2.0.0
In Commercial Distribution
- 09355529000095 ()
-
- MRI system application software