Australia TGA ARTG record

General ultrasound imaging system, battery-powered

Australia TGA ARTG Registered Device · Sonictec · Sonostar Technologies Co Limited · Class IIa · Started April 30, 2019

Good Name: Sonictec - General ultrasound imaging system, battery-powered

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 30, 2019
Effective Date: April 30, 2019

Sponsor

Name: Sonictec

Manufacturer

Name: Sonostar Technologies Co Limited
Country: China
Address: 504 C Building 27 Yayingshi Road Science Town, Guangzhou, 510665

Intended purpose

A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed.

About this record

Access comprehensive regulatory information for General ultrasound imaging system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sonictec, manufactured by Sonostar Technologies Co Limited in China. The device registration started on April 30, 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.