510(k) K253784 ยท LLZ System, Image Processing, Radiological
3DICOM MD Cloud
| Applicant | Singular Health Pty, Ltd., Leederville, AU |
| Decision | Substantially Equivalent, Jan 8, 2026 |
| Received | Nov 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253784
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.