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Company Files 510(k) for Prostate Imaging System
ProUroCare Medical has filed a 510(k) application with
the FDA for its prostate mechanical imaging system, according to a company statement. The device is intended for use as an aid to visualize abnormalities
of the prostate detected in a digital rectal examination. The tactile elasticity imaging technology creates a “map” of the prostate and an
electronic record that can be stored for future analysis.
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