510(k) K123508 ยท OWB Interventional Fluoroscopic X-Ray System
TRINIAS
| Applicant | Shimadzu Corporation, Kyoto, JP |
| Decision | Substantially Equivalent, Feb 26, 2014 |
| Received | Nov 13, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K123508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Oct 22, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray Open, Classified |
OWB | None listed |
| Mar 14, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Shimadzu, Trinias, Digital Angiography System Open, Classified |
OWB | None listed |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Shimadzu Trinias
Generator Model: D150GC-40 Open, Classified |
OWB | None listed |
| Nov 18, 2020 | Shimadzu Medical Systems Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, Open, Classified |
OWB | None listed |
| Nov 4, 2019 | Shimadzu Medical Systems Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, Completed |
OWB | None listed |
| Jan 14, 2019 | Shimadzu Medical Systems Usa Com TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose ang Terminated |
OWB | None listed |
| Oct 19, 2018 | Shimadzu Medical Systems Usa Com TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiogr Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.