510(k) K111209 ยท IZI System, X-Ray, Angiographic
INTEGRATED INNOVA - S5I SYSTEM OPTION
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Jul 26, 2011 |
| Received | Apr 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2019 | GE Healthcare, LLC Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention Open, Classified |
IZI | None listed |
| Oct 5, 2018 | GE Medical Systems, SCS Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.