510(k) K232189 ยท LLZ System, Image Processing, Radiological
OrionXR
| Applicant | Hoth Intelligence, Inc., Philadelphia PA, US |
| Decision | Substantially Equivalent, Sep 14, 2023 |
| Received | Jul 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232189
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.