510(k) K151451 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jul 9, 2015 |
| Received | May 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2017 | Toshiba American Medical Systems Inc APLIO 300 TUS-A300
diagnostic ultrasound system Terminated |
IYN | None listed |
| May 1, 2017 | Toshiba American Medical Systems Inc APLIO 500 TUS-A500
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.