510(k) K152696 ยท OWB Interventional Fluoroscopic X-Ray System
INFX-8000V, V6.20
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jan 12, 2016 |
| Received | Sep 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152696
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.