510(k) K162583 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ALOKA LISENDO 880
| Applicant | Hitachi , Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Sep 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Lisendo 880 Ultrasound
Software Version: V1.0 through V4.1.3 Open, Classified |
IYN | None listed |
| 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.