ARTG 322700Ultrasound system, imaging, mammography
ARTG ID: 322700 · GE Healthcare Australia Pty Ltd · GE Medical Systems Ultrasound and Primary Care Diagnostics LLC · Class IIa · Started September 04, 2019
Good Name: GE Healthcare Australia Pty Ltd - Ultrasound system, imaging, mammography
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 322700
- Start Date
- September 04, 2019
- Effective Date
- September 04, 2019
- Country
- United States of America
- Address
- 9900 Innovation Drive, Wauwatosa, WI, 53226
This ultrasound device is intended for use as an adjunct 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.
Access comprehensive regulatory information for Ultrasound system, imaging, mammography in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 322700 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics LLC in United States of America. The device registration started on September 04, 2019.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.