510(k) K222470 ยท LLZ System, Image Processing, Radiological
3Dicom MD
| Applicant | Singular Health Pty, Ltd., Subiaco, AU |
| Decision | Substantially Equivalent, Oct 25, 2022 |
| Received | Aug 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222470
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.