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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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No Description
ELEKTA, INC.
ERGO Localizer
Not in Commercial Distribution

  • 00858164002213 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
ERGO++
Not in Commercial Distribution

  • 00858164002206 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002190 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002183 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002169 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002152 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
XiO
Not in Commercial Distribution

  • 00858164002114 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002046 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Atlas-Based Autosegmentation
Not in Commercial Distribution

  • 00858164002039 ()


  • Radiation therapy software
The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images. The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
Icad, Inc.
3.5
In Commercial Distribution

  • 00858012005786 ()
D4D0185

  • Radiological PACS software
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