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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
CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms.
LUMEDX CORPORATION
6.4.3
In Commercial Distribution
- 00857560008003 ()
113-00749
- Radiological PACS software
SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution
- 00859626006282 ()
ML-830-07-003
- Laser application software
DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution
- 00859626006190 ()
ML-830-04-002
- Laser application software
No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution
- 05711117180497 ()
- Camera application software
No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution
- 05711117199765 ()
- Camera application software
No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution
- 00860002177786 ()
910-01957
- Alarm application software
Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution
- 00860001790825 ()
- Neuromuscular rehabilitation software
InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution
- 00860001790801 ()
- Neuromuscular rehabilitation software