Device Dossier
Ultrasound system, imaging, mammography
Device Dossier for Ultrasound system, imaging, mammography (Ultrasound system, imaging, mammography, Class IIa, sponsor GE Healthcare). ARTG record,…
- GMDN category: Ultrasound system, imaging, mammography
- Sponsor: GE Healthcare
Intended purpose
This ultrasound device is intended for use as an adjuct to mammography, to provide physicians with an increase in the sensitivity of breast cancer detection for screening asymptomatic women. The ultrasound device may also be used for diagnostic ultrasound imaging of the breast.