510(k) K111582 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ S8
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 26, 2011 |
| Received | Jun 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2013 | GE Healthcare, LLC GE Healthcare, LOGIQ S8 Ultrasound System
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neo Terminated |
IYN | None listed |
| Apr 11, 2013 | GE Healthcare, LLC GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The Terminated |
IYN | None listed |
| Feb 23, 2012 | GE Healthcare, LLC GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software.
Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Peripheral Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.