510(k) K180601 ยท OAS X-Ray, Tomography, Computed, Dental
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
| Applicant | Villa Sistemi Medicali S.P.A., Buccinasco, IT |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Mar 7, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K180601
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.