TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K041639) manufactured by Envisioneering, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2004. Regulation: 8.