FDAnews
www.fdanews.com/articles/122538-company-files-510-k-for-prostate-imaging-system

Company Files 510(k) for Prostate Imaging System

November 27, 2009
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.