COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO

COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO is an FDA 510(k)-cleared medical device (K090991) manufactured by E-Woo Technology. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 2009. Regulation: 8.