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…
- GMDN category: Ultrasound system, imaging, application program software
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.