510(k) K183456 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aloka Arietta 850
| Applicant | Hitachi Healthcare Americas, Twinsburg OH, US |
| Decision | Substantially Equivalent, Jan 28, 2019 |
| Received | Dec 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 850 Ultrasound-
Software Version: V1.0.0 through V4.1.3 Open, Classified |
IYN | None listed |
| Jun 30, 2021 | Hitachi Healthcare Americas Corporation Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during
robotic/non-robotic intra-operative and laparoscopic procedures Open, Classified |
IYN | None listed |
| Mar 1, 2021 | Hitachi Medical Systems America Inc Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operativ Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.