510(k) K945375 ยท IZI System, X-Ray, Angiographic
ADVANTX LCA
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 30, 1995 |
| Received | Nov 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | GE Healthcare, LLC ADVANTX LCA Terminated |
IZI | None listed |
| Dec 18, 2015 | GE Medical Systems, LLC Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, I Terminated |
OWB | None listed |
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ.
Intended for general purpose diagnostic fluoroscopy and radiography studies. Terminated |
OWB | None listed |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies. Terminated |
MQB | None listed |
| Sep 21, 2008 | GE Healthcare Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies. Terminated |
MQB | None listed |
| Sep 16, 2008 | GE Healthcare Advantx-E is an angiographic X-Ray system. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.