510(k) K193216 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
syngo.CT Lung CAD
| Applicant | Siemens Medi Cal Solutions, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 9, 2020 |
| Received | Nov 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193216
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.