
Direx Systems Corp.
Free shipping on orders over $99 · 30-day returns
TRACKLEAF-10 is an FDA 510(k)-cleared medical device (K071701) manufactured by Direx Systems 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 July 22, 2007. Regulation: 8.