510(k) K230209 ยท QIH Automated Radiological Image Processing Software
Sonix Health
| Applicant | Ontact Health Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 20, 2023 |
| Received | Jan 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230209
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.