ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K970508) manufactured by Shimadzu Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 3, 1997. Regulation: 8.