CHICAGO – GE Healthcare announced Monday the 510(k) clearance of its next generation wireless, digital X-ray detector FlashPad at the annual meeting of the Radiological Society of North America. The technology is designed to help radiologists transition from film to digital imaging and increase access for patients worldwide.

The 510(k) clearance, required by the U.S. Food and Drug Administration, is also known as pre-market notification.

GE bills the FlashPad as the only wireless digital detector available today capable of supporting advanced applications. Designed for digital use based on customer input, FlashPad is a flexible, wireless detector that features two handles that make it easier to position and maneuver. GE executives describe it as equipped with GE's most advanced X-ray detector technology, and they say its unique design provides up to 8 percent more coverage for key applications and maintains high image quality at low dose levels.

The wireless DR option was engineered to provide high image quality at low dose levels and can be used in all routine radiography exams and in specialized areas including, pediatric work, intensive care and trauma, and wherever conventional screen-film systems may be used.

"FlashPad is a byproduct of direct customer feedback on the challenges facing radiology departments all over the world," said Anne LeGrand, vice president and general manager of X-Ray for GE Healthcare. "For the patient, this new solution from GE allows for improved access to critical X-ray technology and for customers, this innovation is a great way for any radiography department to go digital today with an affordable investment that answers the growing demand for advanced applications."

Among the advanced applications that can be performed using FlashPad, are:

VolumeRAD - GE's version of digital tomosynthesis for radiography removes overlaying and underlying structures, which improves the detection of lesions and therefore enhances sensitivity. VolumeRAD provides physicians multiple high-resolution slice images of the human anatomy, including the chest, abdomen, extremities and spine, using an X-ray system.

Dual Energy Subtraction - GE's digital X-ray application eliminates overlying bone obstruction from chest or abdominal images.

FlashPad is at the heart of several radiography products from the company:
Discovery XR656; DR Imaging Option for Proteus XR/a; DR Imaging Option for Precision 500D; Optima XR220 amx and Optima XR200 amx (510(k) pending at FDA. Not available for sale in the United States).