U.S. Food and Drug Administration
Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA
Published in Medical Letter on the CDC and FDA, January 3rd, 2010
Dilon Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its lesion-localization system for molecular imaging biopsy guidance. GammaLoc® is a complementary technology to Dilon's cornerstone product, the Dilon 6800® Gamma Camera. The GammaLoc® (GL) system will help doctors accurately locate breast lesions and enable gamma-guided biopsies, particularly useful for patients that have findings on the Dilon system that are not revealed with other imaging modalities. The GammaLoc® system utilizes a CorreLocator™ paddle and a StereoView™ imaging collimator system - a technique similar to that used in stereotactic...
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