510(k) K052157 ยท JAK System, X-Ray, Tomography, Computed
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 25, 2005 |
| Received | Aug 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 17, 2010 | GE Healthcare, LLC Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
The Innova systems are indicated for Terminated |
MQB | None listed |
| Nov 17, 2010 | GE Healthcare, 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 |
| Nov 17, 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 |
| May 26, 2010 | Ge Healthcare, Llc GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital de Terminated |
MQB | None listed |
| May 26, 2010 | Ge Healthcare, Llc GE Healthcare, Innova 3100 IQ : 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 d Terminated |
MQB | None listed |
| May 26, 2010 | Ge Healthcare, Llc GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
MQB | None listed |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System 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 |
| 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 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 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
IZI | 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 |
| Jun 19, 2009 | GE Medical Systems, LLC GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188.
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular an 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 |
| Jan 21, 2009 | GE Medical Systems, LLC GE Innova 2100IQ Versatile Cardiac and Vascular 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 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 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human a Terminated |
MQB | None listed |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascu Terminated |
MQB | None listed |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | None listed |
| Sep 20, 2008 | GE Healthcare Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Indicated for use in generating flu 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 |
| Sep 16, 2008 | GE Healthcare Innova 2100IQ is a Digital Fluoroscopic Imaging 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 |
| 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 |
| 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 |
| 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.