510(k) K150087 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
| Applicant | Ge Vingmed Ultrasound AS, Horten, NO |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Jan 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2024 | GE Vingmed Ultrasound As GE Vivid Ultrasound products, Model Numbers:
a) Vivid E90, H45581LB;
b) Vivid E95, H45581DA Open, Classified |
IYN | None listed |
| 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 |
| Mar 10, 2017 | GE Healthcare, LLC Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. Terminated |
IYN | None listed |
| Mar 10, 2017 | GE Healthcare, LLC Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.