Data / Medical devices / Australia / Singular Health Pty Ltd
Singular Health Pty Ltd: FDA-registered device maker in Leederville Western Australia, Australia, 2 510(k) clearances
Singular Health Pty Ltd is registered with the FDA (registration 3024078470) in Leederville Western Australia, Australia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024078470
- Address
- E3/661 Newcastle Street, Leederville Western Australia, Australia, 6007
- Owner or operator
- Singular Health Pty Ltd (10086614)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 24, 2022
- Registered through
- 2026
- Brand names listed
- 3DICOM MD Cloud, 3Dicom MD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 8, 2026 | K253784 | 3DICOM MD Cloud | LLZ | Substantially Equivalent | Singular Health Pty, Ltd. | accessdata.fda.gov |
| October 25, 2022 | K222470 | 3Dicom MD | LLZ | Substantially Equivalent | Singular Health Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 8, 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.