510(k) K200873 ยท QAS Radiological Computer-Assisted Triage And Notification Software
HALO
| Applicant | Nico-Lab B.V., Amsterdam, NL |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Apr 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200873
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.