510(k) K093466 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Jun 17, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2011 | Hitachi Medical Systems America Inc Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10).
The Preirus and Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.