510(k) K120201 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
| Applicant | Ge Vingmed Ultrasound AS, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Apr 19, 2012 |
| Received | Jan 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120201
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2013 | GE Healthcare, LLC GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiol Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.