510(k) K033244 ยท OWB Interventional Fluoroscopic X-Ray System
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 16, 2003 |
| Received | Oct 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2014 | GE Healthcare, LLC GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version Terminated |
OWB | None listed |
| Jun 28, 2013 | GE Healthcare, LLC GE Healthcare, Innova 3100 and Innova 4100 systems.
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is inten Terminated |
OWB | None listed |
| Apr 18, 2013 | GE Healthcare, LLC GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ,
Cardiovascular and Interventional Imaging System. Terminated |
OWB | None listed |
| Mar 13, 2013 | GE Healthcare, LLC GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ,
Innova3100IQ, and Innova4100IQ equipped with Video Monitor
Suspension Cardiovascular X-ray imaging systems. Model numbers 2236 Terminated |
MQB | None listed |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 2100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally Terminated |
MQB | None listed |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 3100/ 3100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and opti Terminated |
MQB | None listed |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 4100/4100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and opti Terminated |
MQB | None listed |
| Nov 9, 2009 | GE Medical Systems, LLC GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.