Data / Medical devices / Automated Radiological Image Processing Software / Australia
FDA-registered makers of Automated Radiological Image Processing Software in Australia: 6 establishments
6 establishments in Australia are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Australia
Makers of Automated Radiological Image Processing Software in Australia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 4dmedical Limited | Carlton Victoria, Australia | Manufacturer | 2 | August 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Artrya | Perth Western Australia, Australia | Complaint file establishment, Exporter to the US, Manufacturer | 2 | August 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Omniscient Neurotechnology Pty Ltd (o8t) | Haymarket New South Wales, Australia | Complaint file establishment, Manufacturer | 1 | September 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sydney Neuroimaging Analysis Centre Pty Ltd | Camperdown New South Wales, Australia | Manufacturer | 1 | December 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kico Knee Innovation Company | Frenchs Forest New South Wales, Australia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| See-Mode Technologies Pty Ltd | Melbourne Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.