FDA grants 510(k) clearance to Samsung’s GC70 DR system

26 April 2017 (Last Updated April 26th, 2017 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to market Samsung NeuroLogica's GC70 digital radiography (DR) system.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to market Samsung NeuroLogica's GC70 digital radiography (DR) system.

The GC70 employs the S-Vue imaging engine to provide high-resolution images using adaptive filtering.

The system also features workflow enhancements such as S-Align to enable precise alignment at different angles, and facilitate radiographic alignment in imaging gurney or wheelchair patients, by broadcasting the degree of angulation of the detector to the tube head.

The GC70 minimises the unnecessary radiation dose by allowing accurate collimation using a four-axis, individual blade control function, which is considered useful during pediatric chest examinations.

Samsung NeuroLogica president and chief executive officer Philip Sullivan said: “The GC70 is leading a new generation of digital radiography systems that will make X-rays safer and healthcare more efficient for both patients and care providers.

"With FDA clearance of the GC70 and the GM85, health systems have two powerful new options for inpatient and ambulatory settings that represent affordability with quality care."

“With FDA clearance of the GC70 and the GM85, health systems have two powerful new options for inpatient and ambulatory settings that represent affordability with quality care.”

The GC70 also includes SimGrid to enhance image quality, S-Guide for viewing patients on a screen using a camera, SmartStitching to diagnose a stitched image of a whole spine or long bone, and Bone Suppression Imaging (BSI) for improved clarity of lung tissue.

The system comes with lightweight wireless S-Detectors in a variety of sizes, making it suitable for patients of all ages and with any body habitus.

It also features system customisation and tailored configurations, allowing adaptability at various service lines such as dedicated chest rooms, outpatient clinics, and orthopedic practices.