510(k) K160559 · IYN System, Imaging, Pulsed Doppler, Ultrasonic
NOBLUS Ultrasound Diagnostic System
| Applicant | Hitachi Medical Corporation, Wallingford CT, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2024 | FUJIFILM Healthcare Americas Corporation Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model : AHM250PS24 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.