510(k) K162190 ยท MUH System, X-Ray, Extraoral Source, Digital
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
| Applicant | Villa Sistemi Medicali S.P.A., Buccinasco, IT |
| Decision | Substantially Equivalent, Jul 6, 2017 |
| Received | Aug 4, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K162190
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.