OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K022877) manufactured by Vision Chips, 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 February 4, 2003. Regulation: 8.