SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM

SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K992761) manufactured by Medison America, 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 August 31, 1999. Regulation: 8.