510(k) K230497 ยท QIH Automated Radiological Image Processing Software
Bladder AI (AIBV01)
| Applicant | Exo, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 22, 2023 |
| Received | Feb 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230497
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.