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

DeepUnity Viewer is a web-based image viewer intended to be used for viewing image data, medical documents and reports. DeepUnity Viewer can either be used: • as a stand-alone application, including patient search functionality and integrated authentication, • or integrated within another leading application (like ORBIS) from where it is opened via a context-based call. The leading application is responsible for user authorization and access control of patient data. Medical Purpose DeepUnity Viewer drives clinical management by assisting physicians in the diagnostic process through visualization and processing (including image manipulation) of DICOM images (such as radiological, pathological and cardiological images) and DICOM ECG waveforms, providing relevant information and tools for measurement, analysis and calculation of image characteristics (e.g. geometrical, annotation, Window Level, ROI analysis, linking of either radiological or pathological images) which are potentially related to anomalies. DeepUnity Viewer 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 Viewer features a pathology module that allows the examination of anatomical pathology images (Whole Slide Images) derived from human body specimens. Due to the nature of the device, the clinical performance is not disease specific. DeepUnity Viewer 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 The DeepUnity Viewer enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses and administrators, to view patient images, ECG waveforms, medical documents and reports from multiple departments and perform image manipulations and measurements.

TGA Public Summary