KODAK XLS 8600 (PS)

KODAK XLS 8600 (PS) is an FDA 510(k)-cleared medical device (K951948) manufactured by Kodak Health Imaging Systems, 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 September 12, 1995. Regulation: 8.