Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIa, sponsor…

Intended purpose

Quicktome Software Suite is composed of a configurable base platform and optional advanced modules that can be enabled through software configuration, all intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, image fusion, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, automated and manual segmentation object creation, detection, and adjustment, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets. Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds. Quicktome can be used in conjunction with other clinical methods as an aid in visualization of deep brain structures, such as the subthalamic nuclei (STN), globus pallidus interna (GPi), and ventral intermediate nucleus (VIM). Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists.