510(k) K163702 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, May 30, 2017 |
| Received | Dec 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163702
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2018 | Toshiba American Medical Systems Inc Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.