PROSTATE MECHANICAL IMAGER

PROSTATE MECHANICAL IMAGER is an FDA 510(k)-cleared medical device (DEN100016) manufactured by Artann Laboratories, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2012. Regulation: 8.