MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM is an FDA 510(k)-cleared medical device (K002936) manufactured by Sectra-Imtec AB. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2000. Regulation: 8.