510(k) K121062 ยท ITX Transducer, Ultrasonic, Diagnostic
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Ge Medical System Israel , Ltd., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 17, 2012 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121062
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2022 | GE Medical Systems, LLC Vivid q ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult a Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.