510(k) K160184 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson S6, Voluson S8, Voluson S10
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Feb 25, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2024 | GE HEALTHCARE AUSTRIA GMBH & CO GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.