510(k) K091658 ยท OWB Interventional Fluoroscopic X-Ray System
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 29, 2009 |
| Received | Jun 9, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091658
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.