HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE

HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE is an FDA 510(k)-cleared medical device (K801060) 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 June 3, 1980. Regulation: 8.