Ausonics Pty, Ltd.
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- Devices
- 27
What Ausonics Pty, Ltd. makes
Ausonics Pty Ltd manufactures diagnostic imaging equipment, including mammography units like the ALPHA S/D and ALPHA II X-ray systems, as well as real-time ultrasound scanners such as the OPUS 2 and OPUS 1 with annular array options. Their portfolio also includes ultrasound probes (e.g., 3.5 MHz, 7.5 MHz bi-plane rectal, and transvaginal probes) and specialized imaging devices like the UROIMAGER for urological applications.
The company’s products are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance registry. These devices are intended for medical imaging in diagnostic settings and are listed under U.S. jurisdiction.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Ausonics Pty, Ltd. have in the registry?
The registry currently lists 27 devices for Ausonics Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ausonics Pty, Ltd.'s devices?
Among its 27 most recently registered devices, Ausonics Pty, Ltd. has devices listed in FDA 510(k) (27 devices).
What risk classes do Ausonics Pty, Ltd.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Ausonics Pty, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ausonics Pty, Ltd. in the registry?
The most recently registered devices listed for Ausonics Pty, Ltd. include ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT, AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER, AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION and 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA.