510(k) K122457 ยท OWB Interventional Fluoroscopic X-Ray System
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Jan 2, 2013 |
| Received | Aug 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2019 | GE Healthcare, LLC Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventi Open, Classified |
IZI | None listed |
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 730 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | None listed |
| Oct 5, 2018 | GE Medical Systems, SCS Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | None listed |
| 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 |
| Nov 13, 2015 | GE Medical Systems, LLC GE Healthcare Optima CL323i
Product Usage:
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anato Terminated |
IZI | None listed |
| Nov 13, 2015 | GE Medical Systems, LLC GE Healthcare Optima IGS 320.
Product Usage:
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anat Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Optima IGS 320.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Discovery IGS 730.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 2100IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 2121IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 3100IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova 3131IQ.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 520.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 530.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 540.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 620.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Innova IGS 630.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Jul 3, 2015 | GE Healthcare GE Healthcare Optima CL 323i.
Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. Terminated |
IZI | None listed |
| Dec 16, 2014 | GE Healthcare, LLC Innova IGS 540
Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and Terminated |
IZI | None listed |
| Jan 28, 2014 | GE Healthcare, LLC GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System.
Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.