510(k) K122114 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ S7 EXPERT, LOGIQ S7 PRO
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Oct 3, 2012 |
| Received | Jul 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.