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This article was originally published in The Gray Sheet

Executive Summary

FDA clears Long Island, New York firm's 510(k) for its Magna- SL "open design" magnetic resonance imaging scanner for extremities. The open system allows physicians "to produce, for the first time, weight-bearing and fully bent-limb scans and eliminates the claustrophobic reactions which cause some patients to refuse scans" in standard full-body MRI scanners, according to Magna-Lab. The system, priced at $500,000, will be sold by Magna- Lab's direct sales force to small hospitals, emergency rooms, and private physicians. The Magna-SL is currently being sold in Europe and the Middle East through a network of distributors



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