Device Dossier

Diagnostic digital imaging system workstation application software

Device Dossier for Diagnostic digital imaging system workstation application software (Diagnostic digital imaging system workstation application…

Intended purpose

InferOperate Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients, including 3D anatomical visualization which provides information for both preoperative surgical planning and intraoperative image display. InferOperate Suite accepts DICOM compliant medical images acquired from a variety of imaging devices. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. It provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, surgical planning, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures. The processing may include the generation of preliminary segmentations of anatomy using software that employs machine learning and other computer vision algorithms, as well as interactive segmentation tools, etc. InferOperate Suite is designed for use by trained professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

TGA Public Summary