510(k) K250543 · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson Performance 16; Voluson Performance 18
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Feb 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250543
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.