510(k) K143046 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Xario 100, V3.0
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Nov 19, 2014 |
| Received | Oct 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2016 | Toshiba American Medical Systems Inc Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.