510(k) K214084 ยท OAS X-Ray, Tomography, Computed, Dental
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
| Applicant | Cefla S.C., Imola (Bo), IT |
| Decision | Substantially Equivalent, Jan 20, 2022 |
| Received | Dec 27, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K214084
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.