510(k) K243628 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid T9/Vivid T8
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, Feb 11, 2025 |
| Received | Nov 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243628
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.