510(k) K042053 ยท OWB Interventional Fluoroscopic X-Ray System
INNOVA 4100, INNOVA 3100
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Jul 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2015 | GE Medical Systems, LLC Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, I Terminated |
OWB | None listed |
| 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 |
| May 14, 2013 | GE Healthcare, LLC GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100.
For use in generating fluoroscopic images of human anatomy for diagnostic and 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 |
| 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 |
| 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 3100 / 3100 IQ, Cardiovascular Imaging System, (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 |
| 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 Medical Systems, LLC Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray s Terminated |
MQB | None listed |
| Sep 24, 2009 | GE Medical Systems, 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 19, 2009 | GE Medical Systems, LLC GE Innova 3100 / 3100 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 |
| 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 GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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 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 3100 / 3100 IQ, Cardiovascular Imaging System, 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 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 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) Terminated |
MQB | None listed |
| Sep 29, 2008 | GE Healthcare GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option. Terminated |
MQB | None listed |
| Sep 29, 2008 | GE Healthcare GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option. Terminated |
MQB | None listed |
| Sep 21, 2008 | GE Healthcare GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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 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 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane
Indicated for use in generating fluoroscopic images of human anatomy fo 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 |
| Jan 31, 2008 | GE Healthcare GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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 Terminated |
MQB | None listed |
| Jan 31, 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) 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 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.