POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM

POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM is an FDA 510(k)-cleared medical device (K911275) manufactured by Positron. 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 8, 1991. Regulation: 8.