510(k) K231396 ยท LLZ System, Image Processing, Radiological
CEPHX- Cephalometric Analysis Software
| Applicant | Orca Dental AI , Ltd., Herzliya, IL |
| Decision | Substantially Equivalent, Jan 31, 2024 |
| Received | May 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231396
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.