510(k) K240053 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Venue Go
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jun 10, 2024 |
| Received | Jan 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | GE Medical Systems, LLC Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP f Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.