510(k) K253366 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ Fortis
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253366
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.