Ultrasound system, imaging, mammography
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-11-2019
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Available from:
GE Healthcare Australia Pty Ltd
Class:
Class IIa
Manufactured by:
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC 9900 Innovation Drive, Wauwatosa, WI, 53226 United States Of America
Therapeutic area:
40764 - Ultrasound system, imaging, mammography
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2019-09-04
