510(k) K231025 ยท QAS Radiological Computer-Assisted Triage And Notification Software
EFAI NeuroSuite CT ICH Assessment System
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Oct 4, 2023 |
| Received | Apr 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231025
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.