MODEL SKI-200 ABDOMINAL SCANNER

MODEL SKI-200 ABDOMINAL SCANNER is an FDA 510(k)-cleared medical device (K800824) manufactured by Smithkline Diagnostics, 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 May 13, 1980. Regulation: 8.