PICTOOLS MEDICAL TOOL KIT MODEL 1.0

PICTOOLS MEDICAL TOOL KIT MODEL 1.0 is an FDA 510(k)-cleared medical device (K982146) manufactured by Pegasus Imaging Corp.. 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 13, 1998. Regulation: 8.