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This article was originally published in The Gray Sheet
CARDIAC MARINERS' DIGITAL SCATTER-FREE FLUOROSCOPIC X-RAY SYSTEM 510(K) is pending at FDA, the company says. Cardiac Mariners submitted the 510(k) during the summer of 1995 and updated it with image data from 10 patients in mid-January at FDA's request. The company is seeking an initial clearance of the device for general fluoroscopic use.
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