510(k) K143225 ยท OWB Interventional Fluoroscopic X-Ray System
INFX-8000V with Wireless Footswitch
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, Tochigi-Ken, JP |
| Decision | Substantially Equivalent, Jan 9, 2015 |
| Received | Nov 10, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Toshiba American Medical Systems Inc INFX-8000V Bi-Plane X-Ray Interventional System
X-ray systems Terminated |
OWB | None listed |
| Apr 6, 2015 | Toshiba American Medical Systems Inc INFX-8000V Interventional Angiography System. CAT-880B catheterization table.
Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is regi Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.