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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
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