510(k) K134016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
| Applicant | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, Wallingford CT, US |
| Decision | Substantially Equivalent, Mar 28, 2014 |
| Received | Dec 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K134016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2020 | Hitachi Medical Systems America Inc UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Dop Terminated |
ITX | None listed |
| May 2, 2017 | Hitachi Medical Systems America Inc Arietta 70 Ultrasound System
Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.