SONOS 5500 IMAGING SYSTEM

SONOS 5500 IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K971116) manufactured by Hewlett-Packard Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 1998. Regulation: 8.