510(k) K113403 ยท OWB Interventional Fluoroscopic X-Ray System
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Nov 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 730 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | None listed |
| May 23, 2016 | GE Medical Systems, LLC GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy. Terminated |
OWB | None listed |
| Jan 14, 2015 | GE Healthcare GE Healthcare, Discovery IGS 730 & Discovery IGS 740.
Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for ca Terminated |
OWB | None listed |
| Sep 18, 2013 | GE Healthcare, LLC GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System.
The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiova Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.