510(k) K022322 ยท OWB Interventional Fluoroscopic X-Ray System
INNOVA AND INNOVA 2000 S
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 8, 2002 |
| Received | Jul 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | GE Healthcare, LLC Innova 2000 Terminated |
OWB | 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 |
| Aug 19, 2010 | GE Healthcare, LLC Innova 2000, manufactured by GE Medical Systems, SCS Terminated |
MQB | None listed |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system Terminated |
MQB | None listed |
| Sep 20, 2008 | GE Healthcare Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | None listed |
| May 24, 2006 | GE Healthcare GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.