510(k) K211788 ยท QAS Radiological Computer-Assisted Triage And Notification Software
HALO
| Applicant | Nicolab B.V., Amsterdam, NL |
| Decision | Substantially Equivalent, Jul 8, 2021 |
| Received | Jun 9, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211788
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.