510(k) K191233 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ARIETTA 750
| Applicant | Hitachi Healthcare Americas, Twinsburg OH, US |
| Decision | Substantially Equivalent, Aug 9, 2019 |
| Received | May 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 750 Ultrasound
Software Version: V1.0.0 through V2.1.3 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.