510(k) K152244 ยท KPR System, X-Ray, Stationary
RADspeed Pro
| Applicant | Shimadzu Corporation, Kyoto, JP |
| Decision | Substantially Equivalent, Jun 20, 2016 |
| Received | Aug 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152244
| 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 |
| May 23, 2017 | Shimadzu Medical Systems Usa Com SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro;
Stationary x-ray system Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.