510(k) K181376 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ARIETTA 65
| Applicant | Hitachi Healthcare Americas Corporation, Twinsburg OH, US |
| Decision | Substantially Equivalent, Jul 18, 2018 |
| Received | May 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 65 Ultrasound
Software Versions: V1.0 through V4.0.0 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.