510(k) K162902 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ARIETTA Prologue Diagnostic Ultrasound system and Transducers
| Applicant | Hitachi , Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Dec 15, 2016 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162902
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.