LORAD 1-650 (INTERNATIONAL 650)

LORAD 1-650 (INTERNATIONAL 650) is an FDA 510(k)-cleared medical device (K992280) manufactured by Lorad 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 2, 1999. Regulation: 8.