510(k) K210791 ยท QIH Automated Radiological Image Processing Software
Us2.v1
| Applicant | Eko.Ai Pte Ltd. D/B/A Us2.Ai, Singapore, SG |
| Decision | Substantially Equivalent, Jul 27, 2021 |
| Received | Mar 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210791
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.