510(k) K121063 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Ge Medical System Israel , Ltd., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 21, 2012 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2022 | GE Medical Systems, LLC Vivid S5 Ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult Open, Classified |
IYN | None listed |
| Dec 22, 2022 | GE Medical Systems, LLC Vivid S6 ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.