VS-100 ILLUMINATION AND IMAGING SYSTEM

VS-100 ILLUMINATION AND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K090800) manufactured by Schoelly Imaging, 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 May 17, 2009. Regulation: 8.