510(k) K061129 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
| Applicant | General Electric Co., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jun 1, 2006 |
| Received | Apr 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061129
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE LOGIQ 9 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 |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.