Device Dossier
Information system software, application program, radiology
Device Dossier for Information system software, application program, radiology (Information system software, application program, radiology, Class IIa,…
- GMDN category: Information system software, application program, radiology
Intended purpose
To receive, store, transmit, post- process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images, DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EBT, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology. Visualization in 2D/3D and 4D are supported for single or multiple datasets, or combinations thereof. The software supports assessment of time-dependent behavior of image intensity, density, dimensions or volume of regions of interest over time. for volumetric or planar dynamic image types such as CT or MR. Parametric mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data. Tools are provided to define and edit paths through structures such as center lines, which may be used to analyze cross- sections of structures, or to provide flythrough visualizations rendered along such a centerline. Segmentation of regions of interest and quantitative analysis tools are provided, for images of vasculature, pathology and morphology.