510(k) K260398 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ e
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, May 26, 2026 |
| Received | Feb 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260398
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.