510(k) K193293 ยท JAK System, X-Ray, Tomography, Computed
XV Lung Ventilation Analysis Software
| Applicant | 4Dx Limited, Melbourne, AU |
| Decision | Substantially Equivalent, May 14, 2020 |
| Received | Nov 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193293
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.