510(k) K152785 ยท OWB Interventional Fluoroscopic X-Ray System
XIDF-AWS801, Angio Workstation, V6.20
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Nov 25, 2015 |
| Received | Sep 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2017 | Toshiba American Medical Systems Inc Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.