FDA Clears Samsung’s Digital Radiography System

Samsung, an emerging force in medical imaging technology, announced that the GC70 Digital Radiography (DR) system received FDA 510(k) clearance for the U.S. market, underscoring the company’s commitment to expanding its suite of radiography products.
 
“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,” said Philip Sullivan, Samsung NeuroLogica president and CEO. “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 creates high-quality images with digital enhancements such as the S-Vue imaging engine, which provides high resolution images through adaptive filtering. Workflow enhancements such as S-Align, a unique and highly practical feature, provides accurate alignment at multiple angles and broadcasts the detector’s degree of angulation to the tube head allowing proper radiographic alignment when imaging gurney or wheel chair patients. This results in improved imaging and reduces repetitive exposures all while saving time. A four-axis, individual blade control function reduces unnecessary radiation dose by enabling more precise collimation. This is especially useful for pediatric chest examinations. A host of streamlined operations simplify workflow to save time during diagnostic procedures. Combined, they offer the ability to enhance the quality of care while increasing patient satisfaction ratings.
 
The GC70 is the latest addition to Samsung’s DR portfolio, which also includes the retrofit GR40CW digital x-ray; the mobile GM60A and GM85 systems; the GU60A U-arm; the floor mounted GF50—an affordable system for physician offices; and the ceiling-mounted GC85A. Optional features radiology practices can order with the GC70 include:
 

• SimGrid increases image quality by enhancing contrast while reducing the visual effects of scatter radiation with one click.
• S-Guide enables technologies to see the patient displayed on screen via camera view in order to simplify the stitching settings. Manual settings for stitching range are replaced with simple clicks on the screen.
• SmartStitching provides convenient diagnosis when viewing a stitched image of a whole spine or long bone. In addition, SmartStitching increases comfort for patients standing for a long period of consecutive shootings.
• Bone Suppression Imaging (BSI) improves the clarity of lung tissue by suppressing the appearance of the ribs and mediastinum in chest images, improving the ability to detect nodules.

 
Lightweight wireless S-Detectors that receive the x-ray signals come in multiple sizes, making the GC70 adaptable for use with patients of different ages and body habitus. Furthermore, tailored configurations of the entire GC70’s component set enable healthcare providers to use the DR system across many different service lines including: dedicated chest rooms, outpatient clinics and orthopedic practices. Disparate medical facilities require various options in order to satisfy diverse clinical needs and physical environments. The GC70 provides those options for efficient system customization.