510(k) K092271 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 17, 2009 |
| Received | Jul 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092271
| 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.