Data / Medical devices / System, Image Processing, Radiological / Australia
FDA-registered makers of System, Image Processing, Radiological in Australia: 13 establishments
13 establishments in Australia are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 10 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
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- Australia
Makers of System, Image Processing, Radiological in Australia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Optimized Ortho Pty Ltd | Sydney New South Wales, Australia | Manufacturer | 3 | November 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Omniscient Neurotechnology Pty Ltd (o8t) | Haymarket New South Wales, Australia | Complaint file establishment, Manufacturer | 2 | May 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Singular Health Pty Ltd | Leederville Western Australia, Australia | Complaint file establishment, Manufacturer | 2 | January 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| 4dmedical Limited | Carlton Victoria, Australia | Manufacturer | 1 | March 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Akunah | Brisbane Queensland, Australia | Manufacturer | 1 | May 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Navbit Pty Ltd | South Eveleigh New South Wales, Australia | Manufacturer | 1 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Resonance Health Analysis Services Pty Ltd | Burswood Western Australia, Australia | Manufacturer | 1 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| See-Mode Technologies Pty Ltd | Melbourne Victoria, Australia | Manufacturer | 1 | September 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Voyager Imaging | Hawthorn East Victoria, Australia | Manufacturer | 1 | September 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Zed Technologies | Melbourne Victoria, Australia | Manufacturer | 1 | April 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Artrya | Perth Western Australia, Australia | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 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 | |
| Sydney Neuroimaging Analysis Centre Pty Ltd | Camperdown New South Wales, 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.