510(k) K110943 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E9
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 22, 2011 |
| Received | Apr 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110943
| 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 |
| Jan 11, 2012 | GE Healthcare, LLC GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1.
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.