NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM

NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K060112) manufactured by Nodecrest, 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 May 4, 2006. Regulation: 8.