510(k) K131514 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
| Applicant | Ge Vingmed Ultrasound AS, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | May 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Vivid E9 ultrasound system
Product Usage:
GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qua Terminated |
IYN | None listed |
| Apr 23, 2014 | GE Healthcare, LLC GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.