510(k) K170823 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid E80, Vivid E90, Vivid E95
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jun 12, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Vivid E80 ultrasound system
Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction Terminated |
IYN | None listed |
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Vivid E90 ultrasound system
Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or unde Terminated |
IYN | None listed |
| Mar 22, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Vivid E95 ultrasound system
Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.