510(k) K023178 ยท OWB Interventional Fluoroscopic X-Ray System
INNOVA 4100
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 26, 2002 |
| Received | Sep 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023178
| 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 |
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ.
Intended for general purpose diagnostic fluoroscopy and radiography studies. 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 |
| Nov 16, 2010 | GE Healthcare, LLC Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector 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 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system 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 |
| Sep 24, 2009 | Ge Healthcare GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).
Indicated for use in gener Terminated |
MQB | None listed |
| Sep 24, 2009 | Ge Healthcare GE Innova 4100-IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).
Indicated for use in ge Terminated |
MQB | None listed |
| Jun 19, 2009 | GE Medical Systems, LLC GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188.
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography Terminated |
MQB | None listed |
| Mar 12, 2009 | GE Medical Systems, LLC Innova 4100 / 4100 IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).
Indicated for use in Terminated |
MQB | None listed |
| Jan 21, 2009 | GE Medical Systems, LLC GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is i Terminated |
MQB | None listed |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System Terminated |
MQB | None listed |
| Sep 21, 2008 | GE Healthcare GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is Terminated |
MQB | None listed |
| Sep 20, 2008 | GE Healthcare Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Indicated for use in Terminated |
MQB | None listed |
| Sep 16, 2008 | GE Healthcare Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Terminated |
MQB | None listed |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular). Terminated |
MQB | None listed |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | None listed |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System). Terminated |
MQB | None listed |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System) Terminated |
MQB | None listed |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | None listed |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) Terminated |
MQB | None listed |
| May 24, 2006 | GE Healthcare GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic 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.