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
HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.6
Not in Commercial Distribution

  • 17540266000029 ()


  • MRI system application software
HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.5
Not in Commercial Distribution

  • 17540266000012 ()


  • MRI system application software
No Description
Change Healthcare Canada Company
14.2.1
In Commercial Distribution

  • 17540262180046 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262180039 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.1
In Commercial Distribution

  • 17540262180022 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.0
In Commercial Distribution

  • 17540262180015 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
1.4.3
In Commercial Distribution

  • 17540262160116 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
1.2.0
Not in Commercial Distribution

  • 17540262160079 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
1.1.1
Not in Commercial Distribution

  • 17540262160062 ()


  • Radiological PACS software
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