510(k) K203518 ยท LLZ System, Image Processing, Radiological
Quicktome
| Applicant | Omniscient Neurotechnology Pty Ltd (O8t), Sydney, AU |
| Decision | Substantially Equivalent, Mar 9, 2021 |
| Received | Dec 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203518
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.