510(k) K031637 ยท OWB Interventional Fluoroscopic X-Ray System
INNOVA 3100
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 22, 2003 |
| Received | May 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031637
| 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 |
| 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 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System 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 |
| 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 Healthcare GE Innova 3100, 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 detector) Terminated |
MQB | None listed |
| Sep 24, 2009 | Ge Healthcare GE Innova 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 detect 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 |
| 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 |
| 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 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) 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 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 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 16, 2008 | GE Healthcare Innova 3100/3100IQ is a 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 |
| 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 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 |
| May 24, 2006 | GE Healthcare GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular 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.