510(k) K203374 · MUH System, X-Ray, Extraoral Source, Digital
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
| Applicant | De Götzen S.R.L., Olgiate Olona, IT |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | Nov 16, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K203374
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.