510(k) K060542 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 31, 2006 |
| Received | Mar 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Vivid 7 ultrasound system
Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified p Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.