510(k) K201382 ยท OAS X-Ray, Tomography, Computed, Dental
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
| Applicant | De Gotzen S.R.L., Olgiate Olona, IT |
| Decision | Substantially Equivalent, Nov 18, 2020 |
| Received | May 26, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K201382
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.