510(k) K173555 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E10
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 20, 2017 |
| Received | Nov 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2019 | GE Healthcare, LLC Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D Terminated |
IYN | None listed |
| Sep 14, 2018 | GE Healthcare, LLC GE LOGIQ E10 Ultrasound System, Model #530000E10.
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, tes Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.