510(k) K233676 ยท QIH Automated Radiological Image Processing Software
Us2.v2
| Applicant | Eko.Ai Pte Ltd. D/B/A Us2.Ai, Singapore, SG |
| Decision | Substantially Equivalent, Apr 1, 2024 |
| Received | Nov 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233676
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.