SmartLight applies for expanded use

SmartLight has long maintained that its motorized light box technology enables radiologists to see more detail in films. The Israeli company hopes that it will soon be able to make those claims in official marketing literature after its U.S. subsidiary filed a 510(k) application with the Food and Drug Administration for expanded performance labeling for the products.

With its current 510(k), SmartLight can market the viewers only as a means of reading x-ray films. If the FDA clears the company’s application for expanded labeling, SmartLight will market the viewers as a technology that enables radiologists to see more detail than conventional light boxes, according to Bob Sohval, president of SmartLight’s U.S. subsidiary in Hackensack, NJ. SmartLight backed its 510(k) filing with the results of a study, completed in January, in which over 1500 radiologists compared images on SmartLight viewers with those of conventional light boxes.