DIAGNOSTIC ULTRASOUND, MODEL 1.0

DIAGNOSTIC ULTRASOUND, MODEL 1.0 is an FDA 510(k)-cleared medical device (K992378) manufactured by Volumetrics Medical Imaging, 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 September 28, 1999. Regulation: 8.