UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE

UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE is an FDA 510(k)-cleared medical device (K936136) manufactured by Ge Dec Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 1994. Regulation: 8.