510(k) K162187 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Xario 100 Diagnostic Ultrasound System, V5.0
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Sep 30, 2016 |
| Received | Aug 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2017 | Toshiba American Medical Systems Inc XARIO 100 TUS-X100
diagnostic ultrasound system Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.