SONOS 100 ULTRASOUND IMAGING SYSTEM

SONOS 100 ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K921036) 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 May 28, 1992. Regulation: 8.