SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110

SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 is an FDA 510(k)-cleared medical device (K070634) manufactured by Soyee Product, Inc.. 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 10, 2007. Regulation: 8.