510(k) K150967 ยท OWB Interventional Fluoroscopic X-Ray System
XIDF-AWS801, Angio Workstation, V6.10
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 18, 2015 |
| Received | Apr 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.