510(k) K192165 ยท LLZ System, Image Processing, Radiological
Acteon Imaging Suite
| Applicant | De Gotzen S.R.L., Olgiate Olona, IT |
| Decision | Substantially Equivalent, Feb 11, 2020 |
| Received | Aug 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192165
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.