510(k) K062360 ยท IZI System, X-Ray, Angiographic
BRANSIST SAFIRE
| Applicant | Shimadzu Corp., Torrance CA, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | Aug 14, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K062360
| 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 |
| Dec 16, 2021 | Shimadzu Medical Systems Digital Angiography System Bransist safire
Generator Model D150GC-40 Open, Classified |
IZI | None listed |
| Nov 18, 2020 | Shimadzu Medical Systems Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and i Open, Classified |
IZI | None listed |
| Jan 14, 2019 | Shimadzu Medical Systems Usa Com BRANSIST safire
Product Usage:
DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.