Device Dossier

Ultrasound system, imaging, application program software

Device Dossier for Ultrasound system, imaging, application program software (Ultrasound system, imaging, application program software, Class IIa, sponsor…

Intended purpose

See-Mode Augmented Reporting Tool (SMART) is a stand-alone, reporting software for analysis, measurement, and reporting of ultrasound images. The software analyses ultrasound images and extracts specific information from them, such as annotations, measurements, and pathology presented in the image. The software generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. The client software is designed to run on a standard desktop or laptop computer.

TGA Public Summary