510(k) K024200 ยท OWB Interventional Fluoroscopic X-Ray System
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 16, 2003 |
| Received | Dec 20, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2010 | GE Healthcare, LLC Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
The Innova systems are indicated for use in generating fluoroscopic images of hum Terminated |
MQB | 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 24, 2009 | GE Medical Systems, LLC GE, Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Innova 2000 The principle system components include a C-arm, image acquisiti 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 |
| Sep 16, 2008 | GE Healthcare Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities. 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.