510(k) K214039 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ P10, LOGIQ P9, LOGIQ P8
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 22, 2022 |
| Received | Dec 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214039
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P10 series with software version R4.5.7 Model Number
5877534 Open, Classified |
IYN | None listed |
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535 Open, Classified |
IYN | None listed |
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.