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FDA clears new SmartLight viewer
The Food and Drug Administration has granted 510(k) clearance to SmartLight for a new motorized version of its novel computer-controlled light box technology. The Haifa, Israel, company on Dec. 12 received the agency's go-ahead for its new line of Smart
The Food and Drug Administration has granted 510(k) clearance to SmartLight for a new motorized version of its novel computer-controlled light box technology. The Haifa, Israel, company on Dec. 12 received the agency's go-ahead for its new line of Smart Motorized Viewers, which SmartLight debuted at last month's Radiological Society of North America meeting (SCAN 11/26/97).
The new viewers include SL8000 and SL8000 DLX, which are based on the same technology developed for SmartLight's other light boxes: An x-ray film is placed on a computer-controlled grid that shuts off light modules in areas that aren't required for image illumination. As a result, there is less glare on the light box, making the image seem clearer and bringing out subtle differences in the film, according to the company.
The new viewers apply motorized viewing technology to the SmartLight concept, enabling batches of films to be loaded onto the viewer and brought up for reading automatically. The system's Archive Wizard function enables software to control the storage and display of images, while I.D. Mode gives radiologists access to their own cases with the push of a button. A HIS/RIS gateway is available to display patient data.
Each viewer in the new motorized line can hold up to 320 14 x 17 films, or 1280 mammography films. SmartLight plans to begin shipping the new viewers by mid-year, with a list price of $70,000 to $85,000 depending on configuration. SmartLight plans to keep its older light boxes in its product line, according to Dan Inbar, chairman and vice president of research.
The high cost of SmartLight's technology relative to conventional light boxes has prompted some industry skepticism regarding the prospects for the viewers' commercial success, but Inbar reports that SmartLight has sold 130 systems since 1996. The company has also been successful in Europe: The Hungarian government has placed an order for 50 systems, and Russia's prominent President Administration Hospital has bought a further 10 viewers.