IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM

IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM is an FDA 510(k)-cleared medical device (K963395) manufactured by Sectra-Imtec AB. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 24, 1996. Regulation: 8.