PORTABLE X-RAY SYSTEM, MODEL HAND-RAY

PORTABLE X-RAY SYSTEM, MODEL HAND-RAY is an FDA 510(k)-cleared medical device (K092772) manufactured by Hanjin Digi-X Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2010. Regulation: 8.