Device Dossier

Ultrasound system, imaging, general-purpose

Device Dossier for Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor Quantum Health Group).…

Intended purpose

A general purpose, mobile, software controlled diagnostic Ultrasound system. Its function is to acquire ultrasound data and to display data as 2D mode, M Mode, Colour Doppler Imaging, Power Doppler imaging, harmonic imaging and PW spectral Doppler mode on the LCD system display. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by qualified health professionals. The clinical applications include; abdomen, OB, gynaecology, contrast agent, small parts, vascular, musculo-skeletal, paediatric abdomen, adult cardiac, paediatric cardiology, TCD, urology, cardiac, thoracic, ophthalmic and dermatology applications.

TGA Public Summary