FDA Clears GE’s New Biplane Imaging Systems

GE Healthcare announced today at the Transcatheter Cardiovascular Therapeutics annual meeting that the FDA gave 510(k) clearance for the Innova 3131IQ and 2121IQ digital flat panel biplane imaging systems, for use in cardiovascular imaging, diagnostic and interventional procedures and three-dimensional imaging of vessels and soft tissue.
The systems cover the full size of the patient’s lateral and frontal anatomy simultaneously for a variety of cardiovascular and neurovascular image guided interventional procedures, reducing the number of x-ray images and contrast injections required.
The Innova IQ platform is capable of imaging the finest vessels and cardiovascular anatomy based on GE-developed digital flat panel technology. The systems also performs 3-D flat panel rotational imaging to produce three-dimensional images of the vascular system, bone and soft tissue in the body.