510(k) K123564 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 18, 2012 |
| Received | Nov 20, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE LOGIQ E9 ultrasound system
Product Usage:
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); N Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.