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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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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.
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
No Description
KONICA MINOLTA, INC.
A4C1
In Commercial Distribution

  • 04560141945166 ()


  • Diagnostic x-ray digital imaging system workstation 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
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