510(k) K142323 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
| Applicant | Ge Medical Systems Israel , Ltd., Tirat Carmel, IL |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Aug 20, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2024 | GE Vingmed Ultrasound As GE Vivid Ultrasound products, Model Numbers:
a) Vivid S70, H45041SW Open, Classified |
IYN | None listed |
| Jul 10, 2023 | GE Vingmed Ultrasound As GE Healthcare Vivid S60, ultrasound device Open, Classified |
IYN | None listed |
| Jul 10, 2023 | GE Vingmed Ultrasound As GE Healthcare Vivid S70, ultrasound device Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.