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In Brief: Paradigm Medical

This article was originally published in The Gray Sheet

Executive Summary

Paradigm Medical: "Software and hardware problems" with the company's Precisionist Thirty Thousand phacoemulsification system "have been corrected and shipments resumed Sept. 18," the company says. The system, cleared by FDA via 510(k) in October 1995, "is based on a workstation manufacturing approach that allows [Precisionist's] ultrasound system to be upgraded to its Photon laser system" once it is cleared by FDA. Paradigm submitted a 510(k) for the Photon system in 1994 ("The Gray Sheet" April 22, 1996, I&W-12). Paradigm also announces 510(k) clearance for the Ocular Flow Analyzer, which measures intraocular pressure and calculates pulsatile blood flow through the eye...

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