GE Medical Systems receives FDA clearance for Innova 4100
NOVEMBER 27--GE Medical Systems (www.gemedical.com), a unit of General Electric Company, has received 510(k) market clearance from the US Food & Drug Administration (FDA) for its Innova 4100.
NOVEMBER 27--GE Medical Systems (www.gemedical.com), a unit of General Electric Company, has received 510(k) market clearance from the US Food & Drug Administration (FDA) for its Innova 4100. This large-format digital flat-panel x-ray system provides detailed, real-time fluoroscopic images of human anatomy for interventional radiological procedures that require exacting precision.
The GE Innova 4100 is expected to help physicians treat a variety of medical disorders including peripheral vascular, cardiovascular, and neurological diseases, uterine fibroids, and other conditions, without major surgery. With the Innova 4100, physicians will be able to see clearly inside a patient with digital real-time imaging while guiding catheters and other medical devices to areas of the body needing treatment.
Specifically, the Innova 4100 can provide physicians with exceptional image clarity with 10 times the dynamic range and a 37% larger field of view. Because physicians can image more anatomy in a single series with the Innova 4100, a complete study can be done with fewer x-ray images, lower x-ray dose, and fewer injections of contrast dye when compared to current systems.
The system features GE's unique Revolution digital flat-panel detector technology. By converting x-ray signals into digital images at the point of acquisition, the Revolution detector captures information over the full range of typical exposures, enables exceptional image clarity with a large field of view, and eliminates the artifacts and distortions of conventional image-intensifier chains.