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LG Electronics Inc.
ASHK100G
In Commercial Distribution
- 00195174099452 ()
- Diagnostic x-ray digital imaging system workstation 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
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
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