510(k) K092004 ยท OWB Interventional Fluoroscopic X-Ray System
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 25, 2009 |
| Received | Jul 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2013 | GE Healthcare, LLC GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging
systems.
For use in generating fluoroscopic images of human anatomy. Terminated |
MQB | None listed |
| Oct 28, 2011 | GE Healthcare, LLC GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System.
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interve Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.