510(k) K123828 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Hitachi Aloka Medical, Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Jan 18, 2013 |
| Received | Dec 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2014 | Hitachi Aloka Medical, Ltd. Prosound F75 or F75
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intr Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.