510(k) K060259 ยท OWB Interventional Fluoroscopic X-Ray System
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Feb 22, 2006 |
| Received | Feb 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2012 | GE Healthcare, LLC GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems.
K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoros Terminated |
MQB | None listed |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems.
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventi Terminated |
MQB | None listed |
| Nov 9, 2009 | GE Medical Systems, LLC Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. Terminated |
JAA | None listed |
| May 19, 2009 | GE Medical Systems, LLC Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anat Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.