AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K923273) manufactured by Acoustic Imaging Technologies Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 1994. Regulation: 8.