Data / Medical devices / Australia / Artrya
Artrya: FDA-registered device maker in Perth Western Australia, Australia, 2 510(k) clearances
Artrya is registered with the FDA (registration 3017233423) in Perth Western Australia, Australia. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017233423
- Address
- 1257 Hay St, West Perth WA 6005, Perth Western Australia, Australia, 6005
- Owner or operator
- Artrya (10089524)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- December 17, 2023
- Registered through
- 2026
- Brand names listed
- Salix Coronary Plaque, Salix® Coronary Anatomy, System for CCTA Image Data
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 20, 2025 | K251837 | Salix Coronary Plaque (V1.0.0) | QIH | Substantially Equivalent | Artrya Limited | accessdata.fda.gov |
| March 27, 2025 | K243038 | Salix Central | QIH | Substantially Equivalent | Artrya Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Medical Device Data System
Updated August 20, 2025. 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.