510(k) K261313 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid Explorer/Vivid Advanced/Vivid Focus
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 2, 2026 |
| Received | Apr 21, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261313
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.