Data / Medical devices / Australia / Akunah
Akunah: FDA-registered device maker in Brisbane Queensland, Australia, 1 510(k) clearance
Akunah is registered with the FDA (registration 3024040179) in Brisbane Queensland, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024040179
- Address
- Suite 307, Level 9, Nicholson St Specialist Centre, 121 Newdegate Street, Greenslopes, QLD, Brisbane Queensland, Australia, 4120
- Owner or operator
- Akunah (10091538)
- Roles
- Manufacturer
- First device listed
- December 2, 2024
- Registered through
- 2026
- Brand names listed
- Reflect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2023 | K222987 | Akunah REFLECT | LLZ | Substantially Equivalent | Akunah Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 10, 2023. 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.