510(k) K203535 ยท OWB Interventional Fluoroscopic X-Ray System
Trinias
| Applicant | Shimadzu Corporation Medical Systems, Kyoto, JP |
| Decision | Substantially Equivalent, Apr 28, 2021 |
| Received | Dec 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2026 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60), Open, Classified |
OWB | None listed |
| Jun 2, 2026 | Shimadzu Medical Systems Digital Angiography System Trinias:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40;
Digital Rad Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.