510(k) K140683 ยท KPR System, X-Ray, Stationary
0180 INTUITION, 0072 PRECISION
| Applicant | Arcoma AB, Naples FL, US |
| Decision | Substantially Equivalent, Jun 3, 2014 |
| Received | Mar 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2022 | Arcoma AB Omnera 400T Digital Radiographic System Open, Classified |
KPR | None listed |
| Jul 5, 2022 | Arcoma AB Omnera 400A Digital Radiographic System Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.