Device Dossier

Radiology picture archiving and communication system application software

Device Dossier for Radiology picture archiving and communication system application software (Radiology picture archiving and communication system…

Intended purpose

Web based PACS software tool including image enhancement features (window levelling, presets, inversion, MIP and MPR), spatial locator and measuring functions for the area of diagnostic radiology. Medical Purpose DeepUnity PACSonWEB aids diagnosis driving clinical management by assisting (nuclear) radiologists in the diagnostic process through visualization and processing (including image manipulation) of DICOM images, providing relevant information and tools for measurement, analysis and calculation of image characteristics (e.g. geometrical, annotation, Window Level, ROI Analysis, linking of radiological images) which are potentially related to diagnostic findings. DeepUnity PACSonWEB is intended to investigate any anatomy of the human body which is visible in medical imaging for the purpose of visualization, detection, or measurement of abnormalities/ diseases/ medical conditions. DeepUnity PACSonWEB is also intended to be used for injury diagnosis - it can be used for any injury that can be diagnosed using medical imaging. Non-medical Purpose DeepUnity PACSonWEB enables healthcare professionals to view patient images, medical documents and reports from multiple departments and perform image manipulations and measurements. The device is used by medical professionals whenever they require access to medical images and patient demographic information. The device is used by patients to access their medical images (primarily) and to read the associated report (if available).

TGA Public Summary