510(k) K133535 ยท OWB Interventional Fluoroscopic X-Ray System
INFX-8000V, V5.30
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Jul 23, 2014 |
| Received | Nov 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM Terminated |
OWB | None listed |
| Feb 9, 2016 | Toshiba American Medical Systems Inc INFX-8000V Bi-Plane X-Ray Interventional System
X-ray systems Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.