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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
Qr8 Health Inc
CHR-COG-W20
In Commercial Distribution

  • 00860007318788 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-23
In Commercial Distribution

  • 00860007318771 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-22
In Commercial Distribution

  • 00860007318757 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution

  • 00860007318740 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-10
Not in Commercial Distribution

  • 00860007318733 ()


  • Cognitive assessment software
3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software
3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402319 ()


  • Radiation therapy software
ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.
PROKNOW, LLC
1.0
In Commercial Distribution

  • 00860000358705 ()


  • Radiological PACS 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
The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device. The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device • Significant displacement of tissue during needle penetration • Image distortion in the MR dataset.
Icad, Inc.
3.5
In Commercial Distribution

  • 00858012005779 ()
D75014-05, D57015-05

  • Radiological PACS software
No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software
No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


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

  • 00858164002268 ()


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

  • 00858164002244 ()


  • Radiation therapy software
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
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