510(k) K170832 ยท OWB Interventional Fluoroscopic X-Ray System
Ultimax-i, DREX-UI80 V1.60
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jul 21, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80
Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.