510(k) K142368 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
| Applicant | Hitachi Aloka Medical, Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Jan 14, 2015 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2020 | Hitachi Medical Systems America Inc UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Dop Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.