Device Dossier
Portable Ultrasound Scanner - Ultrasound system, imaging, general-purpose
Device Dossier for Portable Ultrasound Scanner - Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa,…
- GMDN category: Ultrasound system, imaging, general-purpose
Intended purpose
A battery-powered, hand-held device, designed to scan the external body surface for collection, display and analysis of ultrasound information during a variety of diagnostic ultrasound imaging procedures including Obstetrics (OB), Gynecology (GY) and General imaging. It consists of an ultrasound transducer and includes an integrated image processing system. It may include an integrated display or be intended to wirelessly transmit images to a computer or portable computer device with dedicated, equipment specific, ultrasound imaging software installed, that is supplied as an integral component of the device.