510(k) K133278 ยท OWB Interventional Fluoroscopic X-Ray System
DISCOVERY IGS 740
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Apr 24, 2014 |
| Received | Oct 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 740 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | None listed |
| May 23, 2016 | GE Medical Systems, LLC GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy. Terminated |
OWB | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and im 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 |
| Dec 16, 2014 | GE Healthcare, LLC Discovery IGS 740
Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.