510(k) K173739 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ALOKA ARIETTA 850
| Applicant | Hitachi Healthcare Americas Corporation, Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 28, 2018 |
| Received | Dec 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173739
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.